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Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E

NCT00761501 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2010-12-09

No results posted yet for this study

Summary

The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.

Conditions

  • Healthy Volunteer

Interventions

DRUG

PN400

Oral

DRUG

Naproxen (Proxen S)

Oral

DRUG

Naproxen (Naprosyn E)

Oral

Sponsors & Collaborators

Principal Investigators

  • Mark Sostek, MD · AstraZeneca

  • Aslak Rautio, MD · Quintiles Hermelinen

  • Wolfgang Kuhn, MD · Quintiles Phase I Services

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

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 NCT00761501 on ClinicalTrials.gov