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Guaifenesin and Pseudoephedrine 1200

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Oct 15, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Guaifenesin and Pseudoephedrine 1200 · 1 trial · 1 indication

Phase 1 1
NCT03706300Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting ConditionsHealthy
COMPLETED80 Analytics
PHASE1COMPLETED
Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions
Healthy
NCT0370630080
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Study Endpoints

Primary Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Guaifenesin and Pseudoephedrine Hydrochloride ER TabletsEXPERIMENTALGuaifenesin and Pseudoephedrine Hydrochloride ER Tablets 1200/120 mg of Dr. Reddy's Laboratories Limited
Mucinex DACTIVE_COMPARATORMucinex D extended-release bi-layer tablets 1200/120 mg of Reckitt Benckiser Inc., USA

Interventions

NameTypeDescription
Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mgDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: i. Volunteers who provide written informed consent. ii. Must be healthy, adult, humans between 18 and 45 years of age (both inclusive) weighing at least 55 kg. iii. Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2. iv. M...

Countries:India
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