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Trial record 30 of 7493 for:    Area Under Curve

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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Amlodipine besylate/Atorvastatin calcium Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg
Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg of Dr. Reddys Laboratories Limited
Drug: Amlodipine besylate/Atorvastatin calcium
Amlodipine besylate/Atorvastatin calcium 10/80 mg
Other Name: Caduet

Active Comparator: Caduet
Caduet® 10/80 mg tablets of Pfizer, Ireland
Drug: Amlodipine besylate/Atorvastatin calcium
Amlodipine besylate/Atorvastatin calcium 10/80 mg
Other Name: Caduet




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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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 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.

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): NCT02295046


Locations
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Germany
3S-Pharmacological Consultation & Research GmbH
D-27243 Harpstedt, Koenigsberger, Germany
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Dr. V Parasca, MD 3S-Pharmacological Consultation & Research GmbH

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02295046     History of Changes
Other Study ID Numbers: AMAT-BESD-03-RDL/10
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: December 2011
Additional relevant MeSH terms:
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Calcium, Dietary
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents