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CompletedNCT00650286

Food Study of Modafinil Tablets 200 mg to Provigil® Tablets 200 mg

Single-Dose Food In Vivo Bioequivalence Study of Modafinil Tablets (200 mg; Mylan) to Provigil® Tablets (200 mg; Cephalon) in Healthy Volunteers

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Mylan Pharmaceuticals Inc · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGModafinil Tablets 200 mg200mg, single dose fed
DRUGProvigil® Tablets 200 mg200mg, single dose fed

Timeline

Start date
2002-09-01
Primary completion
2002-10-01
Completion
2002-10-01
First posted
2008-04-01
Last updated
2024-04-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00650286. Inclusion in this directory is not an endorsement.

Food Study of Modafinil Tablets 200 mg to Provigil® Tablets 200 mg (NCT00650286) · Clinical Trials Directory