DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fed Conditions

Information source: Torrent Pharmaceuticals Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Losartan Potassium and Hydrochlorothiazide Tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Torrent Pharmaceuticals Limited

Summary

Objective: to compare the single dose bioavailability of Torrent's Losartan Potassium and Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck & Co., Inc. Study Design: Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects

Clinical Details

Official title: An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Fixed Dose Combination (FDC) of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fed Conditions

Study design: N/A

Primary outcome:

Bioequivalence based on AUC parameters

Bioequivalence based on Cmax

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- The volunteers were excluded 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 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.

Locations and Contacts

Torrent BE Centre, Gandhinagar, Gujarat 382 428, India
Additional Information


Last updated: October 8, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017