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

NCT ID: NCT02295046

Last Updated: 2014-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2011-11-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg

Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg of Dr. Reddys Laboratories Limited

Group Type: EXPERIMENTAL

Amlodipine besylate/Atorvastatin calcium

Intervention Type: DRUG

Amlodipine besylate/Atorvastatin calcium 10/80 mg

Caduet

Caduet® 10/80 mg tablets of Pfizer, Ireland

Group Type: ACTIVE_COMPARATOR

Amlodipine besylate/Atorvastatin calcium

Intervention Type: DRUG

Amlodipine besylate/Atorvastatin calcium 10/80 mg

Interventions

Amlodipine besylate/Atorvastatin calcium

Amlodipine besylate/Atorvastatin calcium 10/80 mg

Intervention Type: DRUG

Other Intervention Names

Caduet

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. V Parasca, MD

Role: PRINCIPAL_INVESTIGATOR

3S-Pharmacological Consultation & Research GmbH

Locations

3S-Pharmacological Consultation & Research GmbH

D-27243 Harpstedt, Koenigsberger, Germany

Countries

Germany

Other Identifiers

AMAT-BESD-03-RDL/10

Identifier Type: -

Identifier Source: org_study_id