Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets
NCT00596245 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2015-04-16
Summary
This is an open-label, parallel group, single-center study. The study design consists of a screening and a treatment period. A total of 42 (approximately 21 of each sex) non-smoking healthy volunteers aged 18 - 35.
Conditions
- Healthy
Interventions
- DRUG
-
MT400
MT 400, naproxen sodium 550mg
Sponsors & Collaborators
-
POZEN
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Matthew M Medlock, MD · PPD Development, LP
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2007-12-31
- Completion
- 2007-12-31
Countries
- United States
Study Locations
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