Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride
Information source: Johnson & Johnson Consumer & Personal Products Worldwide
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasal Congestion
Intervention: Diphenhydramine hydrochloride (Drug)
Phase: Phase 1
Sponsored by: Johnson & Johnson Consumer & Personal Products Worldwide
Official(s) and/or principal investigator(s):
Melissa Israel, BS, Study Director, Affiliation: McNeil Consumer Healthcare Division of McNeil-PPC, Inc.
The purpose of this study is to determine if two formulations of diphenhydramine
hydrochloride are bioequivalent.
Official title: A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule
Study design: Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUC0-t and AUC0-infinity
Secondary outcome: The safety analysis included all subjects who took at least one dose of clinical trial test product and had any follow-up information. Subjects in the safety analysis set were summarized and listed, based on actual treatment received.
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
Following a seven-day washout period, the comparison treatment was administered according to
the same procedure as above.
Minimum age: 18 Years.
Maximum age: 55 Years.
- 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
- 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
- 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
Locations and Contacts
Starting date: October 2006
Ending date: November 2006
Last updated: April 18, 2008