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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

NCT03697889 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-01-23

No results posted yet for this study

Summary

This is a research study designed to evaluate the rate and extent of absorption of Naproxen from a novel Naproxen sodium tablet and Nalgesin naproxen sodium 275 mg.

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.

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Konstantin A. Zacharov, MD · LLC "Scientific and Research centre Eco-safety"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2018-12-17
Completion
2019-01-21

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03697889 on ClinicalTrials.gov