Bioequivalence Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochloride Tablets Under Fasting Conditions.

Study Overview
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Brief Summary
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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
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An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of FDC of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg 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 Fasting Condition.

Official Title
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An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of FDC of Olmesaartan Medoxomil, Amlopdipine and Hydrochlorothiazide (40+10+25) mg Tab [Torrent,India] Vs Tribenzor(40+10+25) mg Tab [ Daichi Sankyo, Inc USA] in Healthy Subjects-Fasted Condition.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets
* Drug: Tribenzor Tablets of Daichi Sankyo Inc, USA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sex: male Age: 18-45 years 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 Exclusion Criteria: 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 due to language problem, poor mental development or impaired cerebral function.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide (40+10+25) mg Tablets | Drug: Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets<br>* Oral, crossover<br>|
| Active Comparator: Reference<br>Tribenzor (40+10+25) mg Tablets of Daichi Sankyo Inc, USA | Drug: Tribenzor Tablets of Daichi Sankyo Inc, USA<br>* Oral, crossover<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | Pre-dose to 72 hours after post dose | 
| AUC |  | Pre-dose to 72 hours after post dose |