NCT00835211

Desmopressin Acetate 0.2 mg Tablets, Fasting

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg Desmopressin Acetate Tablets in Healthy Adult Subjects Following a 0.8 mg Dose Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the single-dose relative bioavailability of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg desmopressin acetate tablets following a 0.8 mg dose under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Desmopressin Acetate 0.2 mg Tablets	4 x 0.2 mg, single-dose fasting
DRUG	DDAVP® 0.2 mg Tablets	4 x 0.2 mg, single-dose fasting

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2009-02-03
• Last updated: 2009-09-11
• Results posted: 2009-08-04

Locations

1 site across 1 country: Canada