Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | October 2009 |
"A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State"
The purpose of this study is to determine the single-dose pharmacokinetics of the
investigational drug PL 3100 following oral administration to healthy volunteers and to
compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.
investigational drug PL 3100 following oral administration to healthy volunteers and to
compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.
Inclusion Criteria:
- Age 18-75 years, inclusive.
- Subject has a Body Mass Index (BMI) between 20 and 32, inclusive.
- Normal physical examination as determined by the Investigator.
- Normal clinical laboratory test results or clinically insignificant results as
determined by the Investigator during the screening visit.
- If female and of child-bearing potential, the subject must have a negative pregnancy
test and is not nursing.
- If female and of child-bearing potential, the subject must agree to use adequate
birth control for the duration of the study.
Exclusion Criteria:
- Subject has a history of chronic alcohol consumption or abuse of narcotics or
alcohol.
- Subject has had an acute illness within 5 days of study medication administration.
- Subject is currently participating, or has participated within 30 days prior to study
entry, in an investigational drug study.
- Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other
NSAID.
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