Clinical Bioequivalence Study on Two Metoprolol Tablet 100mg Formulations

NCT03082352 | Unknown Phase 1 DMC

• 1 other identifier: BABE-P15-100
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare the bioavailability of a generic product of metoprolol with that of a reference product when administered to healthy volunteers under fasting conditions. The test product is BF-Metoprolol Tablets 100mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited and the reference product is Betaloc Tablet 100mg. The plasma kinetic data of metoprolol obtained from two formulations will be used to access the interchangeability of the products.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Peak plasma concentration (Cmax) of metoprolol

  24 hours

• Area under the plasma concentration versus time curve (AUC) of metoprolol

  24 hours

Secondary Outcomes (2)

• Time to maximum concentration (Tmax) of metoprolol

  24 hours

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

  24 hours

Study Arms (2)

BF-Metoprolol Tablet 100mg

EXPERIMENTAL

During the study session, healthy subjects will be administered a single dose of BF-Metoprolol Tablet 100mg after an overnight fast of approximately 10 hours

Drug: BF-Metoprolol Tablet 100mg

Betaloc Tablet 100mg

ACTIVE COMPARATOR

During the study session, healthy subjects will be administered a single dose of Betaloc Tablet 100mg after an overnight fast of approximately 10 hours

Drug: Betaloc Tablet 100mg

Interventions

BF-Metoprolol Tablet 100mg DRUG

BF-Metoprolol Tablet 100mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

Also known as: Metoprolol Tablet 100mg

BF-Metoprolol Tablet 100mg

Betaloc Tablet 100mg DRUG

Betaloc Tablet 100mg will be used as a comparator drug for the BE study

Also known as: Metoprolol Tablet 100mg

Betaloc Tablet 100mg

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 30 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 the screening and until two weeks of last dose administration

You may not qualify if:

• Clinically significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
• Clinically significant abnormality in physical examination, vital sign, laboratory test results, ECG evaluation, urine test, blood chemistry or haematological test
• Regular consumption of tobacco used in any forms
• Regular consumer of alcohol (more than one drink per day)
• Blood donation within 4 weeks prior to the start of the study
• Use of metoprolol within 4 weeks before the study
• Use of antihypertensive medications or other beta blockers within 4 weeks before the study
• Volunteer in any other clinical drug study within 2 months prior to this study
• Hypersensitivity to metoprolol 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

MeSH Terms

Interventions

Metoprolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

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

Central Study Contacts

Evelyn YM Chau

CONTACT

(852) 26323377; bfok@cuhk.edu.hk

Benny SP Fok

CONTACT

(852) 26323377; bfok@cuhk.edu.hk

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

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 17, 2017
• Study Start: August 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share