Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

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

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