Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions

NCT00833664 | Completed Phase 1 Results

• 1 other identifier: 10136025
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Terbinafine

EXPERIMENTAL

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

Lamisil®

ACTIVE COMPARATOR

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

Interventions

Terbinafine HCl 250mg tablets DRUG

1 x 250 mg

Terbinafine

Lamisil® 250 mg Tablets DRUG

1 x 250 mg

Lamisil®

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, 15206-3817, United States

Location

MeSH Terms

Interventions

Terbinafine

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Shirley Ann Kennedy, M.D.

  Novum

  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: January 30, 2009
• First Posted: February 2, 2009
• Study Start: January 1, 2002
• Primary Completion: January 1, 2002
• Study Completion: January 1, 2002
• Last Updated: May 30, 2023
• Results First Posted: August 18, 2009

Record last verified: 2023-05

Locations

US (1)