NCT00779831

Bioequivalence Study on Pseudoephedrine HCl 120 mg ER Tablets Under Fasting Conditions

Comparative, Randomized, Single Dose, 2 Way Crossover Bioavailability Study of Ranbaxy and Warner - Lambert (Sudafed ® 12 Hour) 120 mg Pseudoephedrine Hydrochloride Extended - Release Tablets in Healthy Adult Volunteers Under Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Compare bioavailability of Pseudoephedrine hydrochloride extended release tablets (Ranbaxy Laboratories Limited) against reference product Sudafed ® 12-hour tablets 120 mg (Warner-Lambert) under fasting conditions.

Detailed description

This was an open label, randomized, single dose, 2-way crossover, relative bioavailability study performed on a total of 36 healthy adult subjects (20 males and 16 females). Thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study. In each period, subjects were housed from at least 10 hours before dosing until after the 36 hour blood draw. Single oral 120 mg Pseudoephedrine hydrochloride doses were separated by a washout period of 7 days. A total of thirty six (36) subjects (20 males and 16 females) were enrolled in the study. Out of which a total of thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	120 mg Pseudoephedrine hydrochloride extended release tablets

Timeline

• Start date: 2004-06-01
• Primary completion: 2004-06-01
• Completion: 2004-12-01
• First posted: 2008-10-24
• Last updated: 2008-10-24

Locations

1 site across 1 country: Canada