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Terbinafine HCl 250 mg Tablet Under 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 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.

Clinical Details

Official title: The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under 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 Plasma

AUC0-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, Pittsburgh, Pennsylvania 15206-3817, United States
Additional Information

Starting date: January 2002
Last updated: September 11, 2009

Page last updated: August 23, 2015

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