A clinical trial to study the effect of light meal on Fixed Dose Combination of Aliskiren (300mg)/ Amlodipine (5mg)and Hyderochlorothiazide 25mg) in Healthy human subjects
- Registration Number
- CTRI/2010/091/001323
- Lead Sponsor
- ovartis Healthcare Pvt. Ltd. Raheja IT Park, Mind Space - Bld # 6, Hitech City,Village - Madhapur,Hyderabad 500081, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 124
Healthy male and female subjects, aged 18 to 55 years (inclusive) and in good health as determined by past medical history, physical examination, vital signs assessments, electrocardiogram, and laboratory tests at screening. -
Non-smokers.
-Body mass index (BMI) must be 18 ? 30 kg/m2 (inclusive) and subjects must weigh at least 50 kg.
-Female subjects of child bearing potential.
-Lactating and breast feeding females.
-Hemoglobin levels below 12.0 g/dl.
-A past and current medical history of clinically significant ECG abnormalities.
-A known hypersensitivity or other intolerance to the study drugs or drugs similar to the study drug.
-Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs or which may jeopardize the subject in case of participation in the study.
-A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
-History of head and neck angioedema.
-History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether fixed-dose combination of 300/5/25 mg aliskiren/ amlodipine/ HCTZ tablet is bioequivalent to the free combination of the market formulation of 300 mg aliskiren tablet, and clinical service formulations of 5 mg amlodipine capsule and 25 mg hydrochlorothiazide (HCTZ)<br>capsule in healthy subjects when administered in light meal conditionsTimepoint: nil
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of a single oral dose of the fixed combination and the free combination of aliskiren/ amlodipine/ hydrochlorothiazide 300/5/25 mg in healthy subjectsTimepoint: nil