NCT03706300

Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg of Dr. Reddy's Laboratories Ltd., India Comparing With Mucinex D (Guaifenesin and Pseudoephedrine Hydrochloride) Extended-release Bi-layer Tablets 1200/120 mg of Reckitt Benckiser Inc., USA in Healthy, Adult, Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.

Detailed description

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg of Dr. Reddy's Laboratories Ltd., India comparing with Mucinex D (Guaifenesin and Pseudoephedrine Hydrochloride) extended-release bi-layer tablets 1200/120 mg of Reckitt Benckiser Inc., USA in healthy, adult, human subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2018-10-15
• Last updated: 2018-10-15

Locations

1 site across 1 country: India