Phase 2
Completed N=34
Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
Healthy Volunteers
Source: ClinicalTrials.gov NCT00966641 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Area Under the Curve of Plasma Naproxen From 0 to t — 67763.0; 69427.9 min×μg/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve of Plasma Naproxen From 0 to t |
67763.0; 69427.9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00966641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.