NCT00650013

Fed Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg

Single-Dose Food In Vivo Bioequivalence Study of Midodrine HCl Tablets (5 mg; Mylan) and ProAmatine® Tablets (5 mg; Roberts) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (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 midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Midodrine HCl Tablets 5 mg	5mg, single dose fed
DRUG	ProAmatine® Tablets 5 mg	5mg, single dose fed

Timeline

• Start date: 2002-07-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States