Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Diphenhydramine; Promethazine

Criteria

Inclusion Criteria:

• healthy male and/or female subjects between the ages of 18 and 55 years, inclusive

• approximately 18 to 30 kg/m2 BMI

• total body weight at least 55 kg (121 lbs)

• able to understand and sign the written Informed Consent Form

• willing to follow the protocol requirements and comply with protocol restrictions

Exclusion Criteria:

• pregnant or lactating women

• women of childbearing potential not using acceptable form of contraception 3 months prior to the first dose until completion of follow-up procedures

• history of allergy, sensitivity, and/or idiosyncratic reaction to Benadryl, diphenhydramine hydrochloride, or diphenhydramine citrate

• evidence of clinical, dietary or psychiatric deviation from normal that could increase the risk to the subject or research staff or interfere with the interpretation of study results

• use of licit or illicit drugs

• participated in any other trials within a specified number of days prior to the first dose of the trial treatment