Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions

The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Terbinafine HCl 250mg tablets; Drug: Lamisil® 250 mg Tablets

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206-3817
      • Novum Pharmaceutical Research Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Terbinafine; Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period	Drug: Terbinafine HCl 250mg tablets; 1 x 250 mg
Active Comparator: Lamisil®; Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period	Drug: Lamisil® 250 mg Tablets; 1 x 250 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Concentration - Terbinafine in Plasma	Bioequivalence based on Cmax	Blood samples collected over144 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma	Bioequivalence based on AUC0-inf	Blood samples collected over 144 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma	Bioequivalence based on AUC0-t	Blood samples collected over 144 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Shirley Ann Kennedy, M.D., NOVUM

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): January 1, 2002
• Study Completion (Actual): January 1, 2002

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimated): February 2, 2009

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Terbinafine
• Other Study ID Numbers: 10136025