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Trial record 22 of 3276 for:    Area Under Curve AND Healthy

Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition

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ClinicalTrials.gov Identifier: NCT02295046
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE November 17, 2014
First Posted Date  ICMJE November 19, 2014
Last Update Posted Date November 19, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
Area under curve (AUC) [ Time Frame: 0.50; 1.00; 2.00; 3.00; 4.00; 5.00; 6.00; 7.00; 8.00; 10.00; 11.00; 12.00 16.00; 24.00; 36.00;48.00 and 72.00 hours post dose for Amlodipine ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
Area under curve (AUC) [ Time Frame: 10 min; 20 min; 30 min; 40 min; 50 min; 1.00; 1.25; 1.50; 1.75; 2.00; 2.25; 2.50; 2.75; 3.00; 3.50; 4.00; 4.50; 5.00; 6.00; 8.00; 10.00; 12.00 16.00;24.00; 36.00; 48.00 and 72.00 hours post dose for Atorvastatin ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition
Official Title  ICMJE Open Label, Randomized, Two-treatment, Two-period, Two-sequence,Crossover, Single Dose, Oral Bioequivalence Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10mg/80mg Under Fasting Condition
Brief Summary This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland in Healthy Male and Female Volunteers under Fasting conditions.
Detailed Description Open label, randomized, two-treatment, two-period, two-sequence, crossover, single dose, oral bioequivalence study of Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg under Fasting conditions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Amlodipine besylate/Atorvastatin calcium
Amlodipine besylate/Atorvastatin calcium 10/80 mg
Other Name: Caduet
Study Arms  ICMJE
  • Experimental: Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg
    Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg of Dr. Reddys Laboratories Limited
    Intervention: Drug: Amlodipine besylate/Atorvastatin calcium
  • Active Comparator: Caduet
    Caduet® 10/80 mg tablets of Pfizer, Ireland
    Intervention: Drug: Amlodipine besylate/Atorvastatin calcium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2014)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male and female volunteers between 18 and 55 years of age
  2. Subject with the Body Mass Index within 18.5 and 24.9 kg/m2, weight not less than 50 kg
  3. Normal health as determined by personal medical history, haematology, clinical chemistry and urinalysis laboratory profiles
  4. Non smokers or ex-smokers that gave up smoking for at least two years prior to the study
  5. The subject agrees to abstain from alcohol, food and drinks containing methylxanthines (tea, cola, chocolate) for 48 hours prior to study drug administration and during each study period and from grapefruit-containing food and beverages for 48 hours prior to study drug administration and during each study period
  6. Ability to understand the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the Clinical Investigator and to comply with the requirements of the entire study
  7. Informed written consent given voluntary before the initiation of the pre-study screening
  8. Negative results to the HIV, hepatitis C or hepatitis B test
  9. Negative results from pregnancy tests (for female subjects only)
  10. Non-lactating woman (for female subjects only)
  11. Subjects using non-hormonal contraceptive measures during the study (for female subjects only)
  12. Normal creatine phosphokinase (CPK) levels at the time of check-in of each period.

Exclusion Criteria:

  1. History of hypersensitivity to the test drug (Amlodipine Besylate/Atorvastatin Calcium) or to drugs belonging to the same pharmacological and chemical class and inactive ingredients of the formulation
  2. Participation in a clinical study with an investigational product in the preceding three months or in a clinical study with a generic product in the preceding two months
  3. Hospitalization for any reason within eight weeks prior to the study initiation
  4. Donation of 450 ml or more of blood, within eight weeks prior to the study initiation
  5. Intake of any prescription or non-prescription drug (including anti-acids, analgesics, statins, cyclosporin, fibric acid derivatives, erythromycin, azole antifungals, niacin, oral contraceptives etc.) during the two weeks preceding the study or throughout the study
  6. History of presence of any relevant medical condition including cancer, significant disease of the renal, hepatic, immunological, dermatological, gastrointestinal, respiratory, cardiovascular, endocrine or locomotor systems, and any metabolic, haematological neurological disorder or psychiatric disorder
  7. History or presence of drug or alcohol abuse, within the past year
  8. History or any current condition or other disease known to interfere with the absorption, distribution, metabolism or excretion of investigational medicines
  9. ECG having evidence of clinically significant abnormalities
  10. Presence of any acute or chronic infectious disease
  11. Positive results to the HIV, hepatitis C or hepatitis B tests
  12. Positive results to the breath alcohol test and drugs of abuse checks
  13. Positive results to the pregnancy tests (for female subjects only)
  14. Subject is vegetarian or follows particular diets
  15. A history of difficulty with donating blood.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02295046
Other Study ID Numbers  ICMJE AMAT-BESD-03-RDL/10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. V Parasca, MD 3S-Pharmacological Consultation & Research GmbH
PRS Account Dr. Reddy's Laboratories Limited
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP