Conditions: Pain, Postoperative
Keywords: Naproxen sodium Diphenhydramine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 267
Healthy volunteers: yes

Brief summary:
The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) intervention 2: Naproxen Sodium 440 mg (BAYH6689) intervention 3: DPH 50 mg
Intervention descriptions: intervention 1: Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally. intervention 2: Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally. intervention 3: Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Protocol document: