Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E
Phase I, Open-label, Randomized, 3-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E in Healthy Volunteers
1 other identifier
interventional
38
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2008
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 9, 2010
December 1, 2010
3 months
September 26, 2008
December 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics
pre-dose and multiple times post-dose
Secondary Outcomes (1)
Safety
Throughout study
Study Arms (3)
1
EXPERIMENTAL2
ACTIVE COMPARATOR3
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
- Clinically normal physical exams and laboratory measurements
You may not qualify if:
- Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study
- Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
- Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
- Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Luleå, Sweden
Research Site
Uppsala, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Sostek, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Aslak Rautio, MD
Quintiles Hermelinen
- PRINCIPAL INVESTIGATOR
Wolfgang Kuhn, MD
Quintiles Phase I Services
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 29, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
December 9, 2010
Record last verified: 2010-12