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Naproxen & Pseudoephedrine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 14, 2010

Target and mechanism

ModalitySmall molecule

Also known as Naproxen Sodium & Pseudoephedrine HCl

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Naproxen & Pseudoephedrine · 2 trials · 1 indication

Phase 1 2
NCT01131728Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting ConditionsHealthy
COMPLETED26 Analytics
NCT01131767Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed ConditionsHealthy
COMPLETED26 Analytics
PHASE1COMPLETED
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Naproxen Sodium & Pseudoephedrine HClEXPERIMENTALNaproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg ER Tablets of Dr. Reddy's Laboratories.
Aleve Cold and SinusACTIVE_COMPARATORAleve Cold and Sinus(Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets).

Interventions

NameTypeDescription
Naproxen Sodium & Pseudoephedrine HClDRUGNaproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects must fulfill all of the following criteria to be considered for inclusion into this study: * Subjects will provide written informed consent. * Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg. * Subjects must be within...

Countries:India
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