Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

September 5, 2016 updated by: Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of two to three weeks. During each session, the subjects will be administered a single oral dose of 10mg amlodipine (one BF-Amlodipine Tablet 10mg or one Norvasc Tablet 10mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0 h), and up to 96 h post dose. The plasma concentrations of amlodipine 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 Peak plasma concentration (Cmax), Time to maximum concentration (Tmax), Area under the plasma concentration versus time curve (AUC0-last, AUC0-inf) and Elimination half-life (T1/2). Analysis of Variance (ANOVA) will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one sided 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

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BF-Amlodipine Tablet 10mg
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
BF-Amlodipine Tablet 10mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Other Names:
  • Amlodipine Tablet 10mg
Active Comparator: Norvasc Tablet 10mg
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
Norvasc Tablet 10mg will be used as a comparator drug for the BE study
Other Names:
  • Amlodipine Tablet 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak plasma concentration (Cmax) of amlodipine
Time Frame: 96 hours
96 hours
Area under the plasma concentration versus time curve (AUC) of amlodipine
Time Frame: 96 hours
96 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to maximum concentration (Tmax) of amlodipine
Time Frame: 96 hours
96 hours
Elimination half-life (t1/2) of amlodipine)
Time Frame: 96 hours
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Zhong ZUO, School of Pharmacy, The Chinese Univesity of Hong Kong
  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BABE-P15-097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Study investigators and his/her study team members, domestic and foreign regulatory agencies, the Institutional Review Board/Ethics Committee (IRB/EC) involved in the study, and laboratories and other individuals and organizations that analyze the subjects' protected health information in connection with this study have access to the data or study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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