Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations

NCT ID: NCT03210025

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2017-10-15

Brief 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 plasma pharmacokinetic data of Methyldopa obtained from two formulations will be used to access the interchangeability of the products.

Detailed Description

It is planned to enroll 16 to 30 healthy subjects, with an aim to obtain at least 12 evaluable subjects. 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. 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. 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

BF-Methyldopa Tablet 250mg

During the study session, healthy subjects will be administered a single dose of BF-Methyldopa Tablet 250mg after an overnight fast of approximately 10 hours

Group Type: EXPERIMENTAL

BF-Methyldopa 250mg Tablet

Intervention Type: DRUG

BF-Methyldopa 250mg Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

Metopa Tab 250mg

During the study session, healthy subjects administered a single dose of Metopa Tablet 250mg after an overnight fast of approximately 10 hours

Group Type: ACTIVE_COMPARATOR

Metopa Tab 250mg

Intervention Type: DRUG

Metopa Tab 250mg is manufactured by APT

Interventions

BF-Methyldopa 250mg Tablet

BF-Methyldopa 250mg Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

Intervention Type: DRUG

Metopa Tab 250mg

Metopa Tab 250mg is manufactured by APT

Intervention Type: DRUG

Other Intervention Names

Methyldopa 250mg Tablet; Methyldopa 250mg Tablet

Eligibility Criteria

Inclusion Criteria

• Male and non-pregnant female, 18 to 55 years of age
• Body Mass Index between 18 to 27 kg/m2
• Accessible vein for blood sampling
• High probability for compliance and completion of the study
• Female subjects must agree to practice abstinence or take effective contraceptive methods to prevent pregnancy from the start of screening until two weeks of last dose administration.

Exclusion Criteria

• Clinical significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
• Clinical significant abnormality in physical examination, vital signs, ECG evaluation, urine test, blood chemistry or haematological test
• Tobacco use in any forms
• Regular consumer of alcohol
• Blood donation within 4 weeks prior to the start of the study
• Use of Methyldopa within 4 weeks before the study
• Use of antihypertensive medications within 4 weeks before the study
• Volunteer in any other clinical drug study within 2 months prior to this study
• Hypersensitivity to Methyldopa or other drugs in its class
• History of drug abuse in any form
• Female subjects who are breastfeeding or pregnant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhong Zuo

Role: PRINCIPAL_INVESTIGATOR

School of Pharmacy, The Chinese University of Hong Kong

Riza Ozaki

Role: STUDY_DIRECTOR

Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong

Brian Tomlinsion

Role: STUDY_DIRECTOR

Department of Medicine and Therapeutics, The Chinese University of Hong Kong

Locations

Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

BABE-P15-096

Identifier Type: -

Identifier Source: org_study_id