Status:
COMPLETED
Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Nasal Congestion
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00662337
Start Date
October 1 2006
End Date
November 1 2006
Last Update
September 8 2011
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