Terbinafine HCl 250 mg Tablet Under Fasting Conditions
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ClinicalTrials.gov Identifier: NCT00833586 |
Recruitment Status
:
Completed
First Posted
: February 2, 2009
Results First Posted
: August 18, 2009
Last Update Posted
: September 25, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Terbinafine HCl 250mg tablets Drug: Lamisil® 250 mg Tablets | Phase 1 |
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Fasting Conditions |
Study Start Date : | January 2002 |
Actual Primary Completion Date : | January 2002 |
Actual Study Completion Date : | January 2002 |
Arm | Intervention/treatment |
---|---|
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
|
- Cmax - Maximum Observed Concentration - 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833586
United States, Pennsylvania | |
Novum Pharmaceutical Research Services | |
Pittsburgh, Pennsylvania, United States, 15206-3817 |
Principal Investigator: | Shirley Ann Kennedy, M.D. | Novum |
ClinicalTrials.gov Identifier: | NCT00833586 History of Changes |
Other Study ID Numbers: |
10136024 |
First Posted: | February 2, 2009 Key Record Dates |
Results First Posted: | August 18, 2009 |
Last Update Posted: | September 25, 2009 |
Last Verified: | September 2009 |
Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence Healthy Subjects |
Additional relevant MeSH terms:
Terbinafine Antifungal Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |