Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

NCT02707913 | Completed Phase 1 DMC

• 1 other identifier: BABE-P15-097
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare the bioavailability of a generic product of amlodipine with that of a reference product when administered to healthy volunteers under fasting conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine 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 amlodipine

  96 hours

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

  96 hours

Secondary Outcomes (2)

• Time to maximum concentration (Tmax) of amlodipine

  96 hours

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

  96 hours

Study Arms (2)

BF-Amlodipine Tablet 10mg

EXPERIMENTAL

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

Drug: BF-Amlodipine Tablet 10mg

Norvasc Tablet 10mg

ACTIVE COMPARATOR

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

Drug: Norvasc Tablet 10mg

Interventions

BF-Amlodipine Tablet 10mg DRUG

BF-Amlodipine Tablet 10mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

Also known as: Amlodipine Tablet 10mg

BF-Amlodipine Tablet 10mg

Norvasc Tablet 10mg DRUG

Norvasc Tablet 10mg will be used as a comparator drug for the BE study

Also known as: Amlodipine Tablet 10mg

Norvasc Tablet 10mg

Eligibility Criteria

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

You may qualify if:

• Body Mass Index between 18 to 27
• Accessible vein for blood sampling
• High probability for compliance and completion of the study
• No significant abnormalities in general physical examination
• Electrocardiogram (ECG) recording within normal limits
• Biochemical and haematological parameters within normal limits
• Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until two weeks of last dose administration

You may not qualify if:

• History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
• Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry and 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 amlodipine 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 amlodipine 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

Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhong ZUO

  School of Pharmacy, The Chinese Univesity of Hong Kong

  PRINCIPAL INVESTIGATOR

• Risa Ozaki

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

  STUDY DIRECTOR

• Brian Tomlinson

  Dept. of Medicine and Therapeutics, The Chinese University of Hong Kong

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 14, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share