Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions

NCT01124162 | Completed Phase 1 Results

• 1 other identifier: 30272
• 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 fasting 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 of 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 100mg Tablets

Drug: Losartan

Reference Listed Drug

ACTIVE COMPARATOR

Cozaar® 100 mg Tablets

Drug: Cozaar®

Interventions

Losartan DRUG

100 mg Tablet

Generic Test Product

Cozaar® DRUG

100 mg Tablet

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 of 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.
• Positive testing for hepatitis B, hepatitis C, or HIV at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, diastolic blood pressure lower than 60 or over 100 bpm) at screening.
• Subjects with BMI \> 30.0.
• History of significant alcohol abuse within 6 months prior to screening visit or any indication of the regular use of more than 14 units of alcohol per week (1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
• History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], and 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 or 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Anapharm Inc.

Montreal, Quebec, H3X 2H9, 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
• 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: December 8, 2010
• Results First Posted: July 19, 2010

Record last verified: 2010-11

Locations

CA (1)