NCT00649987

Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg

Single-Dose Fed Bioequivalence Study of Albuterol Sulfate Extended-Release Tablets (8 mg; Mylan) and VoSpire® ER Tablets (8 mg; Pliva) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (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's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Albuterol Sulfate Extended-Release Tablets 8 mg	8mg, single dose fed
DRUG	VoSpire® ER Tablets 8 mg	8mg, single dose fed

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States