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Terbinafine HCl 250 mg Tablet Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00833586
First received: January 30, 2009
Last updated: September 11, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Terbinafine HCl 250mg tablets
Drug: Lamisil® 250 mg Tablets
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration - Terbinafine in Plasma [ Time Frame: Blood samples collected over 144 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma [ Time Frame: Blood samples collected over 144 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma [ Time Frame: Blood samples collected over 144 hour period ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2002
Study Completion Date: January 2002
Primary Completion Date: January 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Terbinafine
Terbinafine HCl 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

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833586

Locations
United States, Pennsylvania
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, United States, 15206-3817
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Shirley Ann Kennedy, M.D. Novum
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00833586     History of Changes
Other Study ID Numbers: 10136024
Study First Received: January 30, 2009
Results First Received: July 6, 2009
Last Updated: September 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Terbinafine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013