Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions

NCT ID: NCT00833664

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2002-01-31

Brief Summary

The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial conditions in healthy, non-tobacco using male and female adult subjects.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Terbinafine

Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period

Group Type: EXPERIMENTAL

Terbinafine HCl 250mg tablets

Intervention Type: DRUG

1 x 250 mg

Lamisil®

Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period

Group Type: ACTIVE_COMPARATOR

Lamisil® 250 mg Tablets

Intervention Type: DRUG

1 x 250 mg

Interventions

Terbinafine HCl 250mg tablets

1 x 250 mg

Intervention Type: DRUG

Lamisil® 250 mg Tablets

1 x 250 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males and females, 18 years or older inclusive with a body mass index (BMI) of 30 or less.
• Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
• Signed and dated informed consent form, which meets all criteria of current FDA regulations
• If female and of child bearing potential subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.

Exclusion Criteria

• If female, pregnant, lactating or likely to become pregnant during the study.
• History of allergy or sensitivity to terbinafine, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
• Significant history or current evidence of chronic evidence of chronic infectious disease, system disorder ot organ dysfunction.
• Presence of gastrointestinal disease ot history of malabsorption within the last year.
• History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
• Presence of a medical condition requiring regular treatment with prescription drugs.
• Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes. within 30 days prior to dosing.
• Receipt of any drug as part of a research study within 30 days prior to dosing.
• Drug or alcohol addition requiring treatment in the past 12 months.
• Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
• Positive test results for drug of abuse at screening.
• Tobacco user within 90 days of the first study dose.
• Unable, or unwilling to tolerate multiple venipunctures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Shirley Ann Kennedy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Novum

Locations

Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

10136025

Identifier Type: -

Identifier Source: org_study_id