Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: PN400 (Drug); Naproxen (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Mark Sostek, MD, Study Director, Affiliation: AstraZeneca
Aslak , Rautio, MD, Principal Investigator, Affiliation: Quintiles Hermelinen
Elisabeth Eden, MD, Principal Investigator, Affiliation: Quintiles AB
Overall contact:
Charlotta Naeslund Quintiles Phase I Services, Phone: +46 18 431 13 36, Email: charlotta.naeslund@quintiles.com
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.
Clinical Details
Official title: Phase I, Open-label, Randomized, 2-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Naprosyn E Under Fasting and Fed Conditions in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Pharmacokinetics
Secondary outcome: Safety
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Charlotta Naeslund Quintiles Phase I Services, Phone: +46 18 431 13 36, Email: charlotta.naeslund@quintiles.com
Research Site, Lulea, Sweden; Recruiting
Research Site, Uppsala, Sweden; Recruiting
Additional Information
Starting date: May 2009
Last updated: October 20, 2009
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