Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Terbinafine HCl 250mg tablets (Drug); Lamisil® 250 mg Tablets (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Teva Pharmaceuticals USA Official(s) and/or principal investigator(s): Shirley Ann Kennedy, M.D., Principal Investigator, Affiliation: Novum
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.
Clinical Details
Official title: The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Cmax - Maximum Observed Concentration - Terbinafine in PlasmaAUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma
Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Novum Pharmaceutical Research Services, Pittsburg, Pennsylvania 15206-3817, United States
Additional Information
Starting date: January 2002
Last updated: September 11, 2009
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