Relative bioavailability between two teriparatide formulations in healthy volunteers.

Farías J, Keller GA, Papouchado M, Villa Etchegoyen MC, Criscuolo ME, Diez RA, Di Girolamo G

International journal of clinical pharmacology and therapeutics1 Aug 2016Cited by 2 (Europe PMC)

PMID27007999DOI10.5414/cp202562PepBankPUB-27007999

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 study7

1 result from studies that gave the peptide. 1 result from people.

01HumanRandomized controlled trialSafety outcome
In healthy volunteers receiving the teriparatide formulations, no subject reported adverse events.
In plain wordsIn healthy volunteers receiving the teriparatide formulations, no participant reported adverse events.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableAdverse events
Study
n = 24
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · single doseAs given in this study (human).
Source sentences
Summary
No subject reported adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers.
Report a problemFND-2700799907

Studies that did not test the peptide alone6

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).

02HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy volunteers, teriparatide Cmax was 165.86 pg/mL for the test formulation and 175.37 pg/mL for the reference.
In plain wordsIn healthy volunteers, peak teriparatide concentrations were 165.86 pg/mL with the test formulation and 175.37 pg/mL with the reference.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedCmax
Study
n = 24
Comparator
Forteo reference formulation
Outcome group
Pharmacokinetics · Pharmacology
Measurements
Cmax
165.86 pg/mL
test
Cmax
175.37 pg/mL
reference
Source sentences
Summary
Geometric mean (90% CI) Cmax for test and reference formulations were 165.86 (153.35 - 212.13) and 175.37 (164.04 - 221.04) pg/mL,
1 context sentence(design, population, supporting numbers)
Summary · context
We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers.
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-2700799901
03HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy volunteers, teriparatide AUC0-t was 14,932 pg×min/mL for the test formulation and 14,153 pg×min/mL for the reference.
In plain wordsIn healthy volunteers, teriparatide exposure to the last sample was 14,932 pg×min/mL with the test formulation versus 14,153 with the reference.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedAUC0-t
Study
n = 24
Comparator
Forteo reference formulation
Outcome group
Pharmacokinetics · Pharmacology
Measurements
AUC0-t
14,932 pg×min/mL
test
AUC0-t
14,153 pg×min/mL
reference
Source sentences
Summary
the AUC0-t was 14,932 (5,275 - 15,752) and 14,153 (1,861 - 16,875) pg×min/mL,
1 context sentence(design, population, supporting numbers)
Summary · context
We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers.
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-2700799902
04HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy volunteers, teriparatide AUC0-∞ was 16,147 pg×min/mL for the test formulation and 15,467 pg×min/mL for the reference.
In plain wordsIn healthy volunteers, total teriparatide exposure was 16,147 pg×min/mL with the test formulation versus 15,467 with the reference.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedAUC0-infinity
Study
n = 24
Comparator
Forteo reference formulation
Outcome group
Pharmacokinetics · Pharmacology
Measurements
AUC0-∞
16,147 pg×min/mL
test
AUC0-∞
15,467 pg×min/mL
reference
Source sentences
Summary
and the AUC0-∞ was 16,147 (15,047 - 18,799) and 15,467 (14,473 - 18,126) pg×min/mL, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers.
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-2700799903
05HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy volunteers, the teriparatide Cmax test/reference ratio was 94.58%, with a 90% CI of 85.29 to 104.87.
In plain wordsIn healthy volunteers, the test formulation had a peak concentration ratio of 94.58% relative to the reference.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedCmax test/reference ratio
Study
n = 24
Comparator
Forteo reference formulation
Outcome group
Pharmacokinetics · Pharmacology
Measurements
Cmax ratio
94.58%
test/reference
Source sentences
Summary
The test/reference ratios (90% CI) for Cmax, AUC0-t, and AUC0-∞ were 94.58% (85.29 - 104.87), 105.5% (97.77 - 113.84), and 104.4% (96.97 - 112.39), respectively No subject reported adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers.
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-2700799904
06HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy volunteers, the teriparatide AUC0-t test/reference ratio was 105.5%, with a 90% CI of 97.77 to 113.84.
In plain wordsIn healthy volunteers, the test formulation had an exposure ratio of 105.5% relative to the reference for AUC0-t.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedAUC0-t test/reference ratio
Study
n = 24
Comparator
Forteo reference formulation
Outcome group
Pharmacokinetics · Pharmacology
Measurements
AUC0-t ratio
105.5%
test/reference
Source sentences
Summary
The test/reference ratios (90% CI) for Cmax, AUC0-t, and AUC0-∞ were 94.58% (85.29 - 104.87), 105.5% (97.77 - 113.84), and 104.4% (96.97 - 112.39), respectively No subject reported adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers.
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-2700799905
07HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy volunteers, the teriparatide AUC0-∞ test/reference ratio was 104.4%, with a 90% CI of 96.97 to 112.39.
In plain wordsIn healthy volunteers, the test formulation had a total exposure ratio of 104.4% relative to the reference.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedAUC0-infinity test/reference ratio
Study
n = 24
Comparator
Forteo reference formulation
Outcome group
Pharmacokinetics · Pharmacology
Measurements
AUC0-∞ ratio
104.4%
test/reference
Source sentences
Summary
The test/reference ratios (90% CI) for Cmax, AUC0-t, and AUC0-∞ were 94.58% (85.29 - 104.87), 105.5% (97.77 - 113.84), and 104.4% (96.97 - 112.39), respectively No subject reported adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers.
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-2700799906

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

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