Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 99 for:    AMLODIPINE AND VALSARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519010
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Collaborator:
Pharmacare PLC, Palestine
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Healthy Drug: Amlodipine/Valsartan Drug: Exforge Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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 Start Date : March 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A Test
Test drug (Amlodipine/Valsartan) 1 tablet contains Amlodipine 10 mg & valsartan 160 mg
Drug: Amlodipine/Valsartan
1 tablet contains Amlodipine 10 mg &valsartan 160 mg
Other Name: Exforge

Active Comparator: B Reference
Reference drug (Exforge) 1 tablet contains Amlodipine 10 mg & valsartan 160 mg
Drug: Exforge
1 tablet contains Amlodipine 10 mg &valsartan 160 mg




Primary Outcome Measures :
  1. Bioequivalence based on Cmax [ Time Frame: Up to 72 hours post dose in each treatment period ]
  2. Bioequivalence based on AUC parameters [ Time Frame: Up to 72 hours post dose in each treatment period ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519010


Locations
Layout table for location information
Egypt
Genuine Research Center GRC
Cairo, Egypt
Sponsors and Collaborators
Genuine Research Center, Egypt
Pharmacare PLC, Palestine
Investigators
Layout table for investigator information
Study Director: Ahmed Elshafeey, Ph.D. Pharma Genuine Research Center

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Genuine Research Center, Egypt
ClinicalTrials.gov Identifier: NCT02519010     History of Changes
Other Study ID Numbers: GRC/1/10/01 CAREPALST
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists