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Trial record 85 of 134 for:    OLMESARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02962336
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets Drug: Tribenzor Tablets of Daichi Sankyo Inc, USA Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test
Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide (40+10+25) mg Tablets
Drug: Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets
Oral, crossover

Active Comparator: Reference
Tribenzor (40+10+25) mg Tablets of Daichi Sankyo Inc, USA
Drug: Tribenzor Tablets of Daichi Sankyo Inc, USA
Oral, crossover

Primary Outcome Measures :
  1. Cmax [ Time Frame: Pre-dose to 72 hours after post dose ]
  2. AUC [ Time Frame: Pre-dose to 72 hours after post dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

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Responsible Party: Torrent Pharmaceuticals Limited Identifier: NCT02962336     History of Changes
Other Study ID Numbers: PK-10-155
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Olmesartan Medoxomil
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists