- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00833586
Terbinafine HCl 250 mg Tablet Under Fasting Conditions
September 11, 2009 updated by: Teva Pharmaceuticals USA
The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Fasting Conditions
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15206-3817
- Novum Pharmaceutical Research Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
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
|
1 x 250 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Bioequivalence based on AUC0-inf
|
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
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 144 hour period
|
Cmax - Maximum Observed Concentration - Terbinafine in Plasma
Time Frame: Blood samples collected over 144 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 144 hour period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (ACTUAL)
January 1, 2002
Study Completion (ACTUAL)
January 1, 2002
Study Registration Dates
First Submitted
January 30, 2009
First Submitted That Met QC Criteria
January 30, 2009
First Posted (ESTIMATE)
February 2, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 25, 2009
Last Update Submitted That Met QC Criteria
September 11, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10136024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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