Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)
Overview
- Phase
- Phase 1
- Intervention
- Amlodipine/Valsartan
- Conditions
- Healthy
- Sponsor
- Genuine Research Center, Egypt
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Bioequivalence based on Cmax
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets (Pharmacare, Palestine) and Exforge 10/160 film coated tablets (Novartis Pharma, USA).
Detailed Description
Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or female, age 18 to 55 years, inclusive.
- •Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
- •Medical demographics without evidence of clinically significant deviation from normal medical condition.
- •Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- •Subject does not have allergy to the drugs under investigation.
Exclusion Criteria
- •Subjects with known allergy to the products tested.
- •Subjects whose values of BMI were outside the accepted normal ranges.
- •Female subjects who were pregnant, nursing or taking birth control pills.
- •Medical demographics with evidence of clinically significant deviation from normal medical condition.
- •Results of laboratory tests which are clinically significant.
- •Acute infection within one week preceding first study drug administration.
- •History of drug or alcohol abuse.
- •Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
- •Subject is on a special diet (for example subject is vegetarian).
- •Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
Arms & Interventions
A Test
Test drug (Amlodipine/Valsartan) 1 tablet contains Amlodipine 10 mg \& valsartan 160 mg
Intervention: Amlodipine/Valsartan
B Reference
Reference drug (Exforge) 1 tablet contains Amlodipine 10 mg \& valsartan 160 mg
Intervention: Exforge
Outcomes
Primary Outcomes
Bioequivalence based on Cmax
Time Frame: Up to 72 hours post dose in each treatment period
Bioequivalence based on AUC parameters
Time Frame: Up to 72 hours post dose in each treatment period
Secondary Outcomes
- Safety assessed by vital sign measurement(Up to 72 hours post dose in each treatment period)
- Number of subjects with adverse events (AE)s(Up to 72 hours post dose in each treatment period)
- Measure of clinical laboratory test values to access safety and tolerability(Up to 72 hours post dose in each treatment period)