Key result
Single-dose rhGH shows equivalent bioavailability and IGF responses between healthy Japanese and Caucasian men.
Why the study?
The pharmacokinetics of recombinant human GH were poorly documented in the Japanese adult population, and comparisons of pharmacokinetics, IGF-I, and IGFBP-3 release between Japanese and Caucasian subjects after rhGH administration had not been reported.
Does a single dose of rhGH result in equivalent pharmacokinetic profiles in healthy Japanese and Caucasian male subjects?
RCT (n=80)
double-blind
randomised
No
Does a single dose of rhGH result in equivalent pharmacokinetic profiles in healthy Japanese and Caucasian male subjects?
The pharmacokinetics and bioavailability of recombinant human growth hormone are equivalent between healthy Japanese and Caucasian male subjects.
Answers are grounded in this paper and cite their sources.
Supports identical rhGH dosing in Japanese and Caucasian men; confirms ethnic bioequivalence in RCT.
The study was conducted in a single clinical trial centre (Radiant Research, Honolulu, Hawaii, USA).Healthy, non-smoking Japanese and Caucasian male subjects aged ≥ 20 to ≤ 50, with a body mass index (BMI) of ≥ 17 to ≤ 30 kg/m 2 , were eligible for the study, and key exclusion criteria were regular use of prescription medicine, a history of alcohol or drug abuse, diabetes or a relative with first-degree diabetes Abstract Context: The pharmacokinetics (PK) of the recombinant human GH (rhGH) is poorly documented for the Japanese adult population, and a study comparing the PK, insulin-like growth factor-I (IGF-I) and IGF-bindingprotein-3 (IGFBP-3) release between Japanese and Caucasian subjects after rhGH administration has previously not been reported.Objective: To compare the profiles of serum GH concentrations and the IGF-I and IGFBP-3 responses after administration of identical doses of rhGH to healthy Japanese and Caucasian subjects.Design and Setting: A randomised, double-blind, placebo-controlled, parallel-group study.Participants and Intervention: A total of 80 healthy male subjects (40 Japanese and 40 Caucasians) completed the study.A single dose of rhGH or placebo was administered subcutaneously, and blood samples were drawn up to 24 hours post-administration.Main Outcome Measures: Standard PK parameters, including the area under the GH concentration-time curve from 0 to 24 hours (AUC [0-24h] ) and maximum GH concentration from 0 to 24 hours (C max ).The IGF-I and IGFBP-3 levels were measured at various timepoints during the sampling period.Results: The bioavailabilities for Japanese and Caucasian subjects in terms of AUC (0-24 h) and C max were considered equivalent.The time to maximum GH concentration from 0-24 hours (t max ) was not statistically different for Japanese and Caucasian subjects.No differences in IGF-I or IGFBP-3 levels were observed. Conclusion:The bioavailabilities of rhGH for Japanese and Caucasian subjects are considered equivalent.Basal circulating IGF-I and IGFBP-3 levels and the release of IGF-I and IGFBP-3 after administration of rhGH were similar between the two ethnic populations.
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Rasmussen MH Christiansen T (2015) conducted an RCT in Healthy (n=80). recombinant human GH (rhGH) vs. placebo was evaluated on Standard PK parameters, including AUC(0-24h) and Cmax. A single dose of recombinant human GH demonstrated equivalent bioavailability (AUC and Cmax) and similar IGF-I and IGFBP-3 responses between healthy Japanese and Caucasian male subjects.
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