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

November 17, 2014 updated by: Dr. Reddy's Laboratories Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Koenigsberger
      • D-27243 Harpstedt, Koenigsberger, Germany
        • 3S-Pharmacological Consultation & Research GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Caduet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Reddy's Laboratories Limited

Investigators

  • Principal Investigator: Dr. V Parasca, MD, 3S-Pharmacological Consultation & Research GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMAT-BESD-03-RDL/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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