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Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

Information source: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nasal Congestion

Intervention: Diphenhydramine hydrochloride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Johnson & Johnson Consumer and 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

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.

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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: October 2006
Last updated: September 7, 2011

Page last updated: August 23, 2015

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