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Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations

2017-07-07 07:08:22 | BioPortfolio

Summary

The objective of the study is to compare the bioavailability of a generic product of methyldopa with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620). The bioequivalence or bioinequivalence of the test and reference formulations will be assessed and concluded based on the plasma pharmacokinetic data of Methyldopa, as well as WHO guidelines on registration requirements to establish interchangeability.

Description

It is planned to enroll 16 to 30 healthy subjects, with an aim to obtain at least 12 evaluable subjects. Selection of subjects will be based on medical history, physical examination, ECG evaluation, urinalysis, blood chemistry and haematological test result. The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, the subjects will be administered a single oral dose of 250mg methyldopa (one BF-Methyldopa Tablet 250mg or one Metopa Tab 250mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0h) and at 0.75 (45min), 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours post-dose (14 time points). The plasma concentrations of methyldopa will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. Anylasis of variance (ANOVA) will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf using the General Linear Model. Appropriate terms for the sequence, subject, period and formulation effects will be included in the statistical model. The two one-side tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax and to assess the bioequivalence of the two products.

Study Design

Conditions

Healthy

Intervention

BF-Methyldopa 250mg Tablet, Metopa Tab 250mg

Status

Not yet recruiting

Source

Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-07-07T07:08:22-0400

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