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

Dr.Reddy's Laboratories

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Amlodipine besylate/Atorvastatin calcium

Study type

Interventional

Funder types

Industry

Identifiers

NCT02295046

AMAT-BESD-03-RDL/10

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female volunteers between 18 and 55 years of age
Subject with the Body Mass Index within 18.5 and 24.9 kg/m2, weight not less than 50 kg
Normal health as determined by personal medical history, haematology, clinical chemistry and urinalysis laboratory profiles
Non smokers or ex-smokers that gave up smoking for at least two years prior to the study
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
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
Informed written consent given voluntary before the initiation of the pre-study screening
Negative results to the HIV, hepatitis C or hepatitis B test
Negative results from pregnancy tests (for female subjects only)
Non-lactating woman (for female subjects only)
Subjects using non-hormonal contraceptive measures during the study (for female subjects only)
Normal creatine phosphokinase (CPK) levels at the time of check-in of each period.

Exclusion criteria

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
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
Hospitalization for any reason within eight weeks prior to the study initiation
Donation of 450 ml or more of blood, within eight weeks prior to the study initiation
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
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
History or presence of drug or alcohol abuse, within the past year
History or any current condition or other disease known to interfere with the absorption, distribution, metabolism or excretion of investigational medicines
ECG having evidence of clinically significant abnormalities
Presence of any acute or chronic infectious disease
Positive results to the HIV, hepatitis C or hepatitis B tests
Positive results to the breath alcohol test and drugs of abuse checks
Positive results to the pregnancy tests (for female subjects only)
Subject is vegetarian or follows particular diets
A history of difficulty with donating blood.