Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions

NCT01124175 | Completed Phase 1 Results

• 1 other identifier: 30273
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 \* 100 mg tablet under fed conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)

  Bioequivalence based on Losartan Cmax.

  Blood samples collected over a 24 hour period.

• AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

  Bioequivalence based on Losartan AUC0-t.

  Blood samples collected over a 24 hour period.

• AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)

  Bioequivalence based on Losartan AUC0-inf.

  Blood samples collected over a 24 hour period.

Secondary Outcomes (3)

• Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)

  Blood samples collected over a 24 hour period.

• AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

  Blood samples collected over a 24 hour period.

• AUC0-inf or Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Infinity)

  Blood samples collected over a 24 hour period.

Study Arms (2)

Generic Test Product

EXPERIMENTAL

Losartan 100 mg Tablets

Drug: Losartan

Reference Listed Drug

ACTIVE COMPARATOR

Cozaar® 100 mg Tablets

Drug: Cozaar®

Interventions

Losartan DRUG

100 mg Tablets

Generic Test Product

Cozaar® DRUG

100 mg Tablets

Also known as: Losartan (generic name)

Reference Listed Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-child-bearing potential female or male.
• Non-smoker
• years or age and older.
• Capable of consent.
• Non-child-bearing potential female subject:
• Post-menopausal state: absence of menses for 12 months prior to drug administration.
• Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.

You may not qualify if:

• Clinically significant illness within 4 weeks prior to the administration of the study medication.
• Clinically significant surgery within 4 weeks prior to the administration of the study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive urine drug screen at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities at screening.
• Subjects with BMI greater than or equal to 30.0.
• History of significant alcohol abuse within 6 months prior to the screening visit or any indication of the regular use of more than 14 units of alcohol per week (1 unit equals 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
• History of drug abuse of use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], or crack) within 1 year prior to the screening visit.
• History of allergic reactions to losartan or other related drugs.
• History of allergic reactions to heparin.
• Use of any drugs known to induce of inhibit drug metabolism within 30 days prior to administration of the study medication.
• Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
• Clinically significant history or presence of any clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Anapharm Inc.

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

Losartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: TEVA Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Richard Larouche, MD

  Anapharm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 14, 2010
• Study Start: October 1, 2003
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: August 19, 2024
• Results First Posted: July 19, 2010

Record last verified: 2024-08

Locations

CA (1)