Safety, tolerability, pharmacokinetics, and pharmacodynamics of recombinant human parathyroid hormone (1-34) in healthy Chinese subjects.

Liu Y, Yang C, Li Z, Zhou J, Lv Y, Zhang Y, Zeng F, Shi S

Clinical therapeutics29 Apr 2014Cited by 4 (Europe PMC)

PMID24793535DOI10.1016/j.clinthera.2014.03.015PepBankPUB-24793535

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study14

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialSafety outcome
In healthy Chinese subjects, rhPTH(1-34) was well tolerated over the tested single and multiple dose ranges.
In plain wordsIn healthy Chinese subjects, rhPTH(1-34) was well tolerated over the tested dose ranges.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableTolerability
Study
n = 42
Outcome group
Adverse events · Pharmacology
Studied dose
single 10-60 μg; multiple 10 and 20 μg once daily · subcutaneous · 7 consecutive days (multiple-dose arms)As given in this study (human).
Source sentences
Summary
Forty-two subjects completed study 1, and 30 subjects completed study 2. rhPTH(1-34) was well tolerated during the investigated single (10-60 μg) and multiple (10-20 μg once daily for 7 consecutive days) dose ranges.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353501
02HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, rhPTH(1-34) reached peak concentration within 20 to 30 minutes after single and multiple doses.
In plain wordsIn healthy Chinese subjects, rhPTH(1-34) reached peak concentration within 20 to 30 minutes.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableTime to peak concentration
Study
n = 30
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single 10, 20 or 40 μg; multiple 20 μg · subcutaneousAs given in this study (human).
Measurements
Tmax
20 to 30 minutes
single and multiple administration
Source sentences
Summary
After single and multiple subcutaneous administration of rhPTH(1-34), the drug was rapidly absorbed, with a Tmax of 20 to 30 minutes, and rapidly cleared from the plasma, with a t½ of 47.2 to 60.6 minutes.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353504
03HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, rhPTH(1-34) had a plasma half-life of 47.2 to 60.6 minutes.
In plain wordsIn healthy Chinese subjects, rhPTH(1-34) had a plasma half-life of 47.2 to 60.6 minutes.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableElimination half-life
Study
n = 30
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single 10, 20 or 40 μg; multiple 20 μg · subcutaneousAs given in this study (human).
Measurements
Half-life
47.2 to 60.6 minutes
single and multiple administration
Source sentences
Summary
After single and multiple subcutaneous administration of rhPTH(1-34), the drug was rapidly absorbed, with a Tmax of 20 to 30 minutes, and rapidly cleared from the plasma, with a t½ of 47.2 to 60.6 minutes.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353505
04HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, mean rhPTH(1-34) Cmax increased proportionally with dose.
In plain wordsIn healthy Chinese subjects, peak rhPTH(1-34) concentrations increased proportionally with dose.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseCmax dose proportionality
Study
n = 30
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single 10, 20 or 40 μg; multiple 20 μg · subcutaneousAs given in this study (human).
Source sentences
Summary
The mean Cmax, AUC0-t, and AUC0-∞ increased in proportion to the doses, whereas the t½, total clearance, and Tmax values were independent of the administered dose.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353506
05HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, mean rhPTH(1-34) AUC0-t increased proportionally with dose.
In plain wordsIn healthy Chinese subjects, rhPTH(1-34) exposure to the last measured time increased proportionally with dose.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseAUC0-t dose proportionality
Study
n = 30
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single 10, 20 or 40 μg; multiple 20 μg · subcutaneousAs given in this study (human).
Source sentences
Summary
The mean Cmax, AUC0-t, and AUC0-∞ increased in proportion to the doses, whereas the t½, total clearance, and Tmax values were independent of the administered dose.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353507
06HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, mean rhPTH(1-34) AUC0-∞ increased proportionally with dose.
In plain wordsIn healthy Chinese subjects, total rhPTH(1-34) exposure increased proportionally with dose.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseAUC0-infinity dose proportionality
Study
n = 30
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single 10, 20 or 40 μg; multiple 20 μg · subcutaneousAs given in this study (human).
Source sentences
Summary
The mean Cmax, AUC0-t, and AUC0-∞ increased in proportion to the doses, whereas the t½, total clearance, and Tmax values were independent of the administered dose.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353508
07HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, rhPTH(1-34) half-life was independent of dose.
In plain wordsIn healthy Chinese subjects, rhPTH(1-34) half-life did not depend on dose.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeHalf-life dose independence
Study
n = 30
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single 10, 20 or 40 μg; multiple 20 μg · subcutaneousAs given in this study (human).
Source sentences
Summary
The mean Cmax, AUC0-t, and AUC0-∞ increased in proportion to the doses, whereas the t½, total clearance, and Tmax values were independent of the administered dose.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353509
08HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, total rhPTH(1-34) clearance was independent of dose.
In plain wordsIn healthy Chinese subjects, rhPTH(1-34) clearance did not depend on dose.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeClearance dose independence
Study
n = 30
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10, 20 or 40 μg single dose; 20 μg multiple dose (study 2) · subcutaneousAs given in this study (human).
Source sentences
Summary
The mean Cmax, AUC0-t, and AUC0-∞ increased in proportion to the doses, whereas the t½, total clearance, and Tmax values were independent of the administered dose.
3 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Summary · context
In study 2, a single dose of rhPTH(1-34) (10, 20, or 40 μg) and a multiple dose of rhPTH(1-34) (20 μg) were administrated subcutaneously to investigate the pharmacokinetic and pharmacodynamic parameters.
Report a problemFND-2479353510
09HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, rhPTH(1-34) Tmax was independent of dose.
In plain wordsIn healthy Chinese subjects, time to peak rhPTH(1-34) concentration did not depend on dose.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeTmax dose independence
Study
n = 30
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10, 20 or 40 μg single dose; 20 μg multiple dose (study 2) · subcutaneousAs given in this study (human).
Source sentences
Summary
The mean Cmax, AUC0-t, and AUC0-∞ increased in proportion to the doses, whereas the t½, total clearance, and Tmax values were independent of the administered dose.
3 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Summary · context
In study 2, a single dose of rhPTH(1-34) (10, 20, or 40 μg) and a multiple dose of rhPTH(1-34) (20 μg) were administrated subcutaneously to investigate the pharmacokinetic and pharmacodynamic parameters.
Report a problemFND-2479353511
10HumanRandomized controlled trialSafety outcome
In healthy Chinese subjects receiving rhPTH(1-34), injection-site erythema was among the most commonly reported adverse events.
In plain wordsIn healthy Chinese subjects receiving rhPTH(1-34), injection-site redness was a commonly reported adverse event.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedInjection-site erythema
Study
n: not reported in source
Outcome group
Adverse events · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
The most generally reported adverse events were erythema at the injection site and gastrointestinal reactions.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353502
11HumanRandomized controlled trialSafety outcome
In healthy Chinese subjects receiving rhPTH(1-34), gastrointestinal reactions were among the most commonly reported adverse events.
In plain wordsIn healthy Chinese subjects receiving rhPTH(1-34), gastrointestinal reactions were commonly reported adverse events.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedGastrointestinal reactions
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
The most generally reported adverse events were erythema at the injection site and gastrointestinal reactions.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353503
12HumanRandomized controlled trialActivity measurement
In healthy Chinese subjects, rhPTH(1-34) produced no significant serum calcium changes or dose-related significant effects.
In plain wordsIn healthy Chinese subjects, serum calcium did not change significantly from baseline or show significant dose-related effects with rhPTH(1-34).
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeSerum calcium
Study
n: not reported in source
Comparator
Baseline
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Compared with the baseline levels, no significant changes or dose-related significant effects were observed in serum calcium and phosphate levels.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353513
13HumanRandomized controlled trialActivity measurement
In healthy Chinese subjects, rhPTH(1-34) produced no significant serum phosphate changes or dose-related significant effects.
In plain wordsIn healthy Chinese subjects, serum phosphate did not change significantly from baseline or show significant dose-related effects with rhPTH(1-34).
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeSerum phosphate
Study
n: not reported in source
Comparator
Baseline
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Compared with the baseline levels, no significant changes or dose-related significant effects were observed in serum calcium and phosphate levels.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
Report a problemFND-2479353514

Studies that did not test the peptide alone1

In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Teriparatide (PTH 1-34).

14HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyPharmacokinetics
In healthy Chinese subjects, pharmacokinetic parameters showed no significant sex differences except Tmax in the 10-μg and 20-μg single-dose groups.
In plain wordsIn healthy Chinese subjects, pharmacokinetics did not significantly differ by sex except peak timing in the 10-μg and 20-μg groups.
Peptide
Teriparatide (PTH 1-34)
Outcome
MixedSex differences in pharmacokinetics
Study
n: not reported in source
Comparator
Other sex
Outcome group
Pharmacokinetics · Pharmacology
Source sentences
Summary
No significant differences in pharmacokinetic parameters were noted by sex except for Tmax in the 10-μg and 20-μg single-dose groups.
2 context sentences(design, population, supporting numbers)
Summary · context
The main aim of the present study was to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of rhPTH(1-34) after single and multiple subcutaneous doses in healthy Chinese subjects.
Summary · context
Two open-label, randomized, single-center, dose-escalation studies were performed.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Report a problemFND-2479353512

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.