A Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Exforge; Drug: Amlodipine/Valsartan

• Registration Number: NCT02519010
• Lead Sponsor: Genuine Research Center, Egypt

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2015-07-30
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-05
• Last Update Submitted: 2015-08-05
• Study First Posted: 2015-08-10
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Healthy male or female, age 18 to 55 years, inclusive.
2. Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
3. Medical demographics without evidence of clinically significant deviation from normal medical condition.
4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
5. Subject does not have allergy to the drugs under investigation.

Exclusion Criteria

1. Subjects with known allergy to the products tested.
2. Subjects whose values of BMI were outside the accepted normal ranges.
3. Female subjects who were pregnant, nursing or taking birth control pills.
4. Medical demographics with evidence of clinically significant deviation from normal medical condition.
5. Results of laboratory tests which are clinically significant.
6. Acute infection within one week preceding first study drug administration.
7. History of drug or alcohol abuse.
8. 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.
9. Subject is on a special diet (for example subject is vegetarian).
10. 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.
11. Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
12. Subject has a history of severe diseases which have direct impact on the study.
13. Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
14. Subject intends to be hospitalized within 3 months after first study drug administration.
15. Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B Reference	Exforge	Reference drug (Exforge) 1 tablet contains Amlodipine 10 mg \& valsartan 160 mg
A Test	Amlodipine/Valsartan	Test drug (Amlodipine/Valsartan) 1 tablet contains Amlodipine 10 mg \& valsartan 160 mg

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on Cmax	Up to 72 hours post dose in each treatment period
Bioequivalence based on AUC parameters	Up to 72 hours post dose in each treatment period

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events (AE)s	Up to 72 hours post dose in each treatment period	Safety and tolerability parameters will include recording of AEs
Safety assessed by vital sign measurement	Up to 72 hours post dose in each treatment period	Vital sign measurement will include blood pressure, pulse rate, respiration rate and body temperature
Measure of clinical laboratory test values to access safety and tolerability	Up to 72 hours post dose in each treatment period	Clinical laboratory tests will include hematology, clinical chemistry and urinalysis

Trial Locations

Locations (1)

Genuine Research Center GRC; 🇪🇬 Cairo, Egypt