Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations

• Status: Completed
• Trial end date: 2017-10-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
• Collaborator: Chinese University of Hong Kong
• Treatments: Methyldopa

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.