Terbinafine HCl 250 mg Tablet Under Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00833586
• Date of registration: 30/01/2009
• Prospective Registration: No
• Primary sponsor: Teva Pharmaceuticals USA
• Public title: Terbinafine HCl 250 mg Tablet Under Fasting Conditions
• Scientific title: The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Fasting Conditions
• Date of first enrolment: January 2002
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00833586
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Canada, United States

Contacts

• Name: Shirley Ann Kennedy, M.D.
• Affiliation: Novum

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Lamisil® 250 mg Tablets

Drug: Terbinafine HCl 250mg tablets

Primary Outcome(s)

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]

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]

Cmax - Maximum Observed Concentration - Terbinafine in Plasma [Time Frame: Blood samples collected over 144 hour period]

Secondary ID(s)

10136024

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/08/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00833586