BE Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab - Fed Conditions
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT02962258
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Brief Summary
Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22 days.
- Detailed Description
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Tribenzor® 40+10+25 mg Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg (Reference , Daichi Sankyo Inc., USA) in Healthy Human Volunteers Under Fed Condition.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 34
- Sex: male
- Age: 18-45 years (inclusive both)
- Volunteer with BMI of 18-25 (inclusive both) kg/m2
- Healthy and willing to participate in the study.
- Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
- Preferably Non-smokers
The volunteers were excluded from the study based on the following criteria:
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG or Chest X-ray.
- Systolic blood pressure less than 110 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.
- Pulse rate less than 60/minute or more than 100/minute. Oral temperature less than 95°F or more than 99°F.
- Respiratory rate less than 14/minute or more than 18/minute
- History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- History of alcohol or drug abuse
- Positive breath alcohol test
- Recent history of kidney or liver dysfunction.
- History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
- Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- History of heart failure.
- HIV, HCV, HBsAg positive volunteers.
- Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
- Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
- Administration of any study drug in the period 0 to 3 months before entry to the study.
- History of significant blood loss due to any reason, including blood donation in the past 3 months.
- History of pre-existing bleeding disorder.
- Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
- Inability to communicate or co-operate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Torrent's Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets Torrent's Olmesrtan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg Reference Tribenzor of Daichi Sankyo Inc. USA Tribenzor of Daichi Sankyo Inc., USA
- Primary Outcome Measures
Name Time Method AUC Pre-dose to 72 hours after post dose Cmax Pre-dose to 72 hours after post dose
- Secondary Outcome Measures
Name Time Method