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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218724
• Other study ID #: PK-07-068
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2010
• Last updated: October 23, 2017

Study information

• Verified date: October 2017
• Source: Torrent Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Losartan Potassium and Hydrochlorothiazide Tablets

Locations

Country	Name	City	State
India	Torrent BE Centre	Gandhinagar	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Torrent Pharmaceuticals Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on AUC parameters
Primary	Bioequivalence based on Cmax