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Study · Randomized controlled trial · n = 76 · 2024

6 results

Bioequivalence of Recombinant Human Teriparatide Injection in Healthy Adult Female Subjects in the Fasting State.

Hu S, Wen Y, Li J, Chen W, Bai Y, Gong F

Clinical pharmacology in drug development24 Jun 2024

PMID38923284 (opens in a new tab)DOI10.1002/cpdd.1440 (opens in a new tab)PepBankPUB-38923284
Publisher pagePubMedAsk about this study
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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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In fasting healthy women, test and reference teriparatide met the bioequivalence criterion for maximum plasma concentration.

    In plain wordsIn fasting healthy women, test and reference teriparatide met the equivalence limit for peak blood concentration.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeMaximum plasma concentration bioequivalence
    Study

    n = 76

    Comparator
    Reference teriparatide preparation
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    The 90% confidence intervals for the geometric mean ratios (T:R) of maximum plasma concentration, area under the plasma concentration-time curve from time 0 to the last measurable concentration, and area under the plasma concentration-time curve from time 0 to infinity
    3 context sentences
    Summary · context
    were within the predefined bioequivalence criterion of 80%-125%, indicating bioequivalence between the T and R preparations under fasting conditions.
    Summary · context
    A single-center, randomized, open, 2-period, self-crossover, single-dose trial was conducted to evaluate the bioequivalence of the test (T) and reference (R) preparations in healthy adult female subjects under fasting conditions.
    Summary · context
    Seventy-six subjects were enrolled in the study, and subjects were randomly divided into 2 groups at a 1:1 ratio and were administered once per period, with a 4-day washout period.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In fasting healthy women, test and reference teriparatide met the bioequivalence criterion for AUC to the last measurable concentration.

    In plain wordsIn fasting healthy women, test and reference teriparatide met the equivalence limit for exposure through the last measurable blood concentration.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeAUC to last measurable concentration bioequivalence
    Study

    n = 76

    Comparator
    Reference teriparatide preparation
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    The 90% confidence intervals for the geometric mean ratios (T:R) of maximum plasma concentration, area under the plasma concentration-time curve from time 0 to the last measurable concentration, and area under the plasma concentration-time curve from time 0 to infinity
    3 context sentences
    Summary · context
    were within the predefined bioequivalence criterion of 80%-125%, indicating bioequivalence between the T and R preparations under fasting conditions.
    Summary · context
    A single-center, randomized, open, 2-period, self-crossover, single-dose trial was conducted to evaluate the bioequivalence of the test (T) and reference (R) preparations in healthy adult female subjects under fasting conditions.
    Summary · context
    Seventy-six subjects were enrolled in the study, and subjects were randomly divided into 2 groups at a 1:1 ratio and were administered once per period, with a 4-day washout period.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In fasting healthy women, test and reference teriparatide met the bioequivalence criterion for AUC to infinity.

    In plain wordsIn fasting healthy women, test and reference teriparatide met the equivalence limit for total blood exposure.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeAUC to infinity bioequivalence
    Study

    n = 76

    Comparator
    Reference teriparatide preparation
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    The 90% confidence intervals for the geometric mean ratios (T:R) of maximum plasma concentration, area under the plasma concentration-time curve from time 0 to the last measurable concentration, and area under the plasma concentration-time curve from time 0 to infinity
    3 context sentences
    Summary · context
    were within the predefined bioequivalence criterion of 80%-125%, indicating bioequivalence between the T and R preparations under fasting conditions.
    Summary · context
    A single-center, randomized, open, 2-period, self-crossover, single-dose trial was conducted to evaluate the bioequivalence of the test (T) and reference (R) preparations in healthy adult female subjects under fasting conditions.
    Summary · context
    Seventy-six subjects were enrolled in the study, and subjects were randomly divided into 2 groups at a 1:1 ratio and were administered once per period, with a 4-day washout period.
  4. 04HumanRandomized controlled trialActivity measurement

    In fasting healthy women, serum calcium levels were comparable with test and reference teriparatide.

    In plain wordsIn fasting healthy women, blood calcium levels were similar with test and reference teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeSerum calcium
    Study

    n = 76

    Comparator
    Reference teriparatide preparation
    Outcome group
    Bone and joint · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Comparable serum calcium levels demonstrated pharmacodynamics similarity, and no differences were found in immunogenicity profiles.
    2 context sentences
    Summary · context
    A single-center, randomized, open, 2-period, self-crossover, single-dose trial was conducted to evaluate the bioequivalence of the test (T) and reference (R) preparations in healthy adult female subjects under fasting conditions.
    Summary · context
    Seventy-six subjects were enrolled in the study, and subjects were randomly divided into 2 groups at a 1:1 ratio and were administered once per period, with a 4-day washout period.
  5. 05HumanRandomized controlled trialSafety outcome

    In fasting healthy women, immunogenicity profiles did not differ between test and reference teriparatide.

    In plain wordsIn fasting healthy women, immune responses did not differ between test and reference teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeImmunogenicity
    Study

    n = 76

    Comparator
    Reference teriparatide preparation
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Comparable serum calcium levels demonstrated pharmacodynamics similarity, and no differences were found in immunogenicity profiles.
    2 context sentences
    Summary · context
    A single-center, randomized, open, 2-period, self-crossover, single-dose trial was conducted to evaluate the bioequivalence of the test (T) and reference (R) preparations in healthy adult female subjects under fasting conditions.
    Summary · context
    Seventy-six subjects were enrolled in the study, and subjects were randomly divided into 2 groups at a 1:1 ratio and were administered once per period, with a 4-day washout period.
  6. 06HumanRandomized controlled trialSafety outcome

    In fasting healthy women, adverse reaction incidence with test teriparatide was reported as 18.4% lower than with reference teriparatide.

    In plain wordsIn fasting healthy women, adverse reactions were less frequent with test teriparatide than with reference teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseAdverse reaction incidence
    Study

    n = 76

    Comparator
    Reference teriparatide preparation
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Reported incidence reduction
    18.4%
    test versus reference
    Adverse reaction incidence
    31.6%
    reference

    Source sentences

    Summary
    Additionally, the incidence of adverse reactions to the T preparation was 18.4% lower than that of the R preparation (31.6%).
    2 context sentences
    Summary · context
    A single-center, randomized, open, 2-period, self-crossover, single-dose trial was conducted to evaluate the bioequivalence of the test (T) and reference (R) preparations in healthy adult female subjects under fasting conditions.
    Summary · context
    Seventy-six subjects were enrolled in the study, and subjects were randomly divided into 2 groups at a 1:1 ratio and were administered once per period, with a 4-day washout period.

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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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