Recent Updates
Recently added Catalysts

Naproxen

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: May 27, 2010

Target and mechanism

ModalitySmall molecule

Also known as Naproxen sodium, Naproxen Sodium

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Naproxen · 2 trials · 1 indication

Phase 1 2
NCT01052129Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting ConditionHealthy
COMPLETED26 Analytics
NCT01052792Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed ConditionsHealthy
COMPLETED26 Analytics
PHASE1COMPLETED
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
2 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Naproxen Sodium 550 mg TabletsEXPERIMENTALNaproxen Sodium 550 mg Tablets of Dr.Reddy's Laboratories Limited
Anaprox DS 550 mg TabletsACTIVE_COMPARATORAnaprox DS 550 mg Tablets of Roche Pharmaceuticals Inc
Anaprox DS 550mg TabletsACTIVE_COMPARATORAnaprox DS 550mg Tablets of Roche Pharmaceuticals Inc

Interventions

NameTypeDescription
Naproxen sodiumDRUGNaproxen Sodium Tablets 550 mg
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy human subjects within the age range of 18 to 45 years. * Non-smokers since at least six months. * Willingness to provide written informed consent to participate in the study. * Body-mass index of ≥18.5 kg/m2 and≤ 24.9 kglm2, with body weight not less than 50 kg. * Abse...

Countries:India
Unlock Eligibility Criteria