Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00833664
First received: January 30, 2009
Last updated: September 11, 2009
Last verified: September 2009

January 30, 2009
September 11, 2009
January 2002
January 2002   (final data collection date for primary outcome measure)
  • Cmax - Maximum Observed Concentration - Terbinafine in Plasma [ Time Frame: Blood samples collected over144 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 ]
Bioequivalence based on Cmax and AUC [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00833664 on ClinicalTrials.gov Archive Site
Not Provided
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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.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Terbinafine HCl 250mg tablets
    1 x 250 mg
  • Drug: Lamisil® 250 mg Tablets
    1 x 250 mg
  • Experimental: Terbinafine
    Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
    Intervention: Drug: Terbinafine HCl 250mg tablets
  • Active Comparator: Lamisil®
    Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
    Intervention: Drug: Lamisil® 250 mg Tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
January 2002
January 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833664
10136025
No
Not Provided
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Shirley Ann Kennedy, M.D. Novum
Teva Pharmaceuticals USA
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP