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

Overview

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).

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2011

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.

Interventions

  • Drug: Amlodipine/Valsartan
    • 1 tablet contains Amlodipine 10 mg &valsartan 160 mg
  • Drug: Exforge
    • 1 tablet contains Amlodipine 10 mg &valsartan 160 mg

Arms, Groups and Cohorts

  • Experimental: A Test
    • Test drug (Amlodipine/Valsartan) 1 tablet contains Amlodipine 10 mg & valsartan 160 mg
  • Active Comparator: B Reference
    • Reference drug (Exforge) 1 tablet contains Amlodipine 10 mg & valsartan 160 mg

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Number of subjects with adverse events (AE)s
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Up to 72 hours post dose in each treatment period
    • Clinical laboratory tests will include hematology, clinical chemistry and urinalysis

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Genuine Research Center, Egypt
  • Collaborator
    • Pharmacare PLC, Palestine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ahmed Elshafeey, Ph.D. Pharma, Study Director, Genuine Research Center

References

Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353. Erratum In: J Pharmacokinet Pharmacodyn. 2002 Feb;29(1):101.

Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.

Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

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