NCT00662337

Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if two formulations of diphenhydramine hydrochloride are bioequivalent.

Detailed description

Subjects were required to observe a ten-hour fast and a one-hour fluid restriction prior to each dosing period. Subjects were randomized into one of two active treatment groups, received supervised dosing of their treatment with approximately eight ounces of water, and were required to maintain fluid restriction for one hour after treatment. Following the one-hour post-dose fluid restriction, subjects could drink water, but consumer no other food or fluids for four hours post-dose. Following a seven-day washout period, the comparison treatment was administered according to the same procedure as above.

Conditions

• Nasal Congestion

Interventions

Type	Name	Description
DRUG	Diphenhydramine hydrochloride	After a ten-hour fast and a one-hour fluid restriction prior to each dosing period, subjects received supervised dosing of their first 25 mg treatment with approximately eight ounces of water. Following a seven-day washout, the comparison treatment was administered according to thye same procedure.

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2008-04-21
• Last updated: 2011-09-08