A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 3, 2018

Primary Completion Date

December 17, 2018

Study Completion Date

January 21, 2019

Conditions
Healthy
Interventions
DRUG

Naproxen sodium (test product)

Participants will be administered single doses of 275 mg Naproxen sodium (test product) tablet orally.

DRUG

Naproxen sodium (reference product)

Participants will be administered single doses of 275 mg Naproxen sodium (reference product - Nalgesin) tablet orally.

Trial Locations (1)

196143

"LLC Scientific and Research centre Eco-safety", Saint Petersburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

McNeil AB

INDUSTRY