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

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ClinicalTrials.gov Identifier: NCT02292069
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : November 17, 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, adult,human subjects under Fed 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, oral bioequivalence study of Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg under Fed conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 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, Oral Bioequivalence Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10mg/80mg Under Fed Condition
Study Start Date : September 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Malnutrition

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: The post dose samples of 4.0 mL were drawn at 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 for Amlodipine assay ]

Secondary Outcome Measures :
  1. Area under curve (AUC) [ Time Frame: post dose samples of 4.0mL were drawn at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.33, 3.67, 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 for Atorvastatin assay ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects aged between 18 and 45 years (both inclusive).
  2. Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
  3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
  4. Subjects having normal 12-lead electrocardiogram (ECG).
  5. Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 01.
  6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
  7. Subjects having negative alcohol breath test.
  8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria:

  1. Hypersensitivity to Amlodipine and Atorvastatin or related class of drugs.
  2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
  4. History or presence of significant alcoholism or drug abuse.
  5. History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
  6. History or presence of asthma, urticaria or other significant allergic reactions.
  7. History or presence of significant gastric and/or duodenal ulceration.
  8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
  9. History or presence of cancer.
  10. Difficulty with donating blood.
  11. Difficulty in swallowing solids like tablets or capsules.
  12. Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
  13. Major illness during 3 months before screening.
  14. Participation in a drug research study within past 3 months.
  15. Donation of blood in the past 3 months before screening.
  16. Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol for within 48 hours prior to dosing.
  17. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
  18. History or presence of significant easy bruising or bleeding.
  19. History or presence of significant recent trauma.

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): NCT02292069


Locations
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India
Veeda Clinical Research Pvt Ltd
Ahmedabad, Gujrat, India, 380 015
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Dr.Gunjan Shah, MD Veeda Clinical Research Pvt. Ltd

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02292069     History of Changes
Other Study ID Numbers: 10-VIN-107
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: December 2011
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
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