Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

Conditions
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Healthy

Intervention / Treatment
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* Drug: BF-Amlodipine Tablet 10mg
* Drug: Norvasc Tablet 10mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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