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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00647647 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride 250 mg tablets to Novartis' Lamisil® 250 mg tablets following a single, oral 250 mg (1 x 250 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Terbinafine Hydrochloride Tablets 250 mg Drug: Lamisil® Tablets 250 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Terbinafine Hydrochloride Tablets (250 mg; Mylan) to Lamisil® Tablets (250 mg; Novartis) in Healthy Volunteers |
| Enrollment: | 36 |
| Study Start Date: | February 2004 |
| Study Completion Date: | March 2004 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Terbinafine Hydrochloride Tablets 250 mg
|
Drug: Terbinafine Hydrochloride Tablets 250 mg
250mg, single dose fasting
|
|
2: Active Comparator
Lamisil® Tablets 250 mg
|
Drug: Lamisil® Tablets 250 mg
250mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | TERB-0392 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00647647 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antifungal Agents Healthy Terbinafine |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antifungal Agents |
Enzyme Inhibitors Pharmacologic Actions Terbinafine |