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

Open label, randomized, two-treatment, two-period, two-sequence, oral bioequivalence study of Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg under Fed conditions.

Inclusion criteria

• Subjects aged between 18 and 45 years (both inclusive).
• 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.
• Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
• Subjects having normal 12-lead electrocardiogram (ECG).
• 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.
• Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Subjects having negative alcohol breath test.
• Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion criteria

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