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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00650286 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg tablets to Cephalon Provigil® 200 mg tablets following a single, oral 200 mg (1 x 200 mg) dose administration under fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Modafinil Tablets 200 mg Drug: Provigil® Tablets 200 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Single-Dose Food In Vivo Bioequivalence Study of Modafinil Tablets (200 mg; Mylan) to Provigil® Tablets (200 mg; Cephalon) in Healthy Volunteers |
| Enrollment: | 20 |
| Study Start Date: | September 2002 |
| Study Completion Date: | October 2002 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Modafinil Tablets 200 mg
|
Drug: Modafinil Tablets 200 mg
200mg, single dose fed
|
|
Active Comparator: 2
Provigil® Tablets 200 mg
|
Drug: Provigil® Tablets 200 mg
200mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and 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 hormonal 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, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00650286 History of Changes |
| Other Study ID Numbers: | MODA-0279 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |