drugset / Trial / NCT01666678
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
RandomizedCrossoverOpen-label
Summary
The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
Timeline
- Start
- 2012-01
- Primary completion
- 2012-02
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diphenhydramine | Unknown | 50 mg | Oral |
| Comparator | Naproxen | Small molecule | 440 mg | Oral |
Indications
No indication recorded.