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.

NCT03706300 Phase 1 COMPLETED

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.

Details

Lead sponsor	Dr. Reddy's Laboratories Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	80
Start date	2014-12
Completion	2015-01

Conditions

• Healthy

Interventions

• Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg

Primary outcomes

• Area under curve — Pre-dose (0.00), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post dose.

Countries

India