Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations

NCT03210025 | Completed Phase 1 DMC

• 1 other identifier: BABE-P15-096
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax of Methyldopa

  24 hours

• AUC of Methyldopa

  24 hours

Secondary Outcomes (2)

• Tmax of Methyldopa

  24 hours

• Elimination half-life (t1/2) of Methyldopa

  24 hours

Study Arms (2)

BF-Methyldopa Tablet 250mg

EXPERIMENTAL

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

Drug: BF-Methyldopa 250mg Tablet

Metopa Tab 250mg

ACTIVE COMPARATOR

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

Drug: Metopa Tab 250mg

Interventions

BF-Methyldopa 250mg Tablet DRUG

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

Also known as: Methyldopa 250mg Tablet

BF-Methyldopa Tablet 250mg

Metopa Tab 250mg DRUG

Metopa Tab 250mg is manufactured by APT

Also known as: Methyldopa 250mg Tablet

Metopa Tab 250mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Tablets; Methyldopa

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Zhong Zuo

  School of Pharmacy, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Riza Ozaki

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

  STUDY DIRECTOR

• Brian Tomlinsion

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-dose, two-treatment, two-period, two-sequence crossover

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 6, 2017
• Study Start: September 20, 2017
• Primary Completion: October 15, 2017
• Study Completion: October 15, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

HK (1)