Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terbinafine | Experimental | Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period |
|
| Lamisil® | Active Comparator | Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbinafine HCl 250mg tablets | Drug | 1 x 250 mg |
| |
| Lamisil® 250 mg Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Concentration - Terbinafine in Plasma | Bioequivalence based on Cmax | Blood samples collected over 144 hour period |
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma | 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 | Bioequivalence based on AUC0-t | Blood samples collected over 144 hour period |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shirley Ann Kennedy, M.D. | Novum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novum Pharmaceutical Research Services | Pittsburgh | Pennsylvania | 15206-3817 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Terbinafine (Test) First | Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period |
| FG001 | Lamisil® (Reference) First | Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout: 14 Days |
| |||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Terbinafine (Test) First | Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period |
| BG001 | Lamisil® (Reference) First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax - Maximum Observed Concentration - Terbinafine in Plasma | Bioequivalence based on Cmax | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jul 2009 | Mean | Standard Deviation | ng/mL | Blood samples collected over 144 hour period |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Biopharmaceutics | Teva Pharmaceuticals USA | 1-866-384-5525 | clinicaltrialqueries@tevausa.com |
| ID | Term |
|---|---|
| D000077291 | Terbinafine |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
1 x 250 mg |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma | Bioequivalence based on AUC0-inf | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jul 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 144 hour period |
|
|
|
|
| Primary | AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma | Bioequivalence based on AUC0-t | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jul 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 144 hour period |
|
|
|
|
Principal Investigator is not permitted to discuss or publish trial results.
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |