Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Cozaar® (100 mg Tablet) [Reference Formulation, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by:
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01218022
First received: October 7, 2010
Last updated: November 1, 2010
Last verified: October 2010
  Purpose

Objective:

The purpose of this study is to compare the single dose bioavailability of Torrent's Losartan Potassium Tablets 1 × 100 mg and Cozaar® Tablets 1 × 100 mg of Merck & Co., Inc.

Study Design:

Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects.


Condition Intervention Phase
Healthy
Drug: Losartan Potassium Tablets
Phase 1

Study Type: Interventional
Official Title: An Open Label, Randomised, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Cozaar® (100 mg Tablet) [Reference Formulation, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fasting Condition

Resource links provided by NLM:


Further study details as provided by Torrent Pharmaceuticals Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax
  • Bioequivalence based on AUC parameters

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Criteria

Inclusion Criteria:

  • The volunteers were Included from the study based on the following criteria:
  • Sex: male.
  • Age: 18 - 45 years. .
  • Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
  • Healthy and willing to participate in the study.
  • Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
  • Non-smokers or smoker who smokes less than 10 cigarettes per day

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 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  • Pulse rate less than 50/minute or more than 100/minute.
  • Oral temperature less than 95°P or more than 98.6°P.
  • Respiratory rate less than 12/minute or more than 20/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 judgement 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218022

Locations
India
Torrent BE Centre
Gandhinagar, Gujarat, India, 382 428
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01218022     History of Changes
Other Study ID Numbers: PK-07-064
Study First Received: October 7, 2010
Last Updated: November 1, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014