NCT00779805

Bioequivalence Study of Pseudoephedrine HCl 120 mg ER Tablets Under Fed Conditions

An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Pseudoephedrine Hydrochloride Formulations Comparing Pseudoephedrine Hydrochloride 120 mg ER Tablets of Ranbaxy Laboratories With Sudafed 120 mg ER Tablets of Pfizer Consumer Health Care in Healthy, Adult, Human Subjects Under Fed Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of the study was to compare the single dose oral bioavailability of Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.

Detailed description

This study was an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioavailability study planned on 40 healthy, adult, human subjects under fed conditions. A total of forty (40) healthy, adult, human subjects were admitted in the study to allow the dosing in the first period. Out of the forty subjects, only thirty eight (38) subjects completed both the periods of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pseudoephedrine hydrochloride 120 mg ER tablets

Timeline

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

Locations

1 site across 1 country: India