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Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide (Industry)
Overall Status
Completed
CT.gov ID
NCT00662337
Collaborator
(none)
36
Enrollment
1
Arm
1
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Diphenhydramine hydrochloride
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Diphenydramine HCl

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.
Other Names:
  • Benadryl Allergy
  • 25 mg KAPSEALS capsule
  • 25 mg ULTRATAB tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUC0-t and AUC0-infinity [At 15 minutes pre-dose (0 hour), and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 36 and 48 hours post-dose]

    Secondary Outcome Measures

    1. 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. [15 minutes pre-dose (0 hour) through 28 days post-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Johnson & Johnson Consumer and Personal Products Worldwide

    Investigators

    • Study Director: Melissa Israel, BS, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnson & Johnson Consumer and Personal Products Worldwide
    ClinicalTrials.gov Identifier:
    NCT00662337
    Other Study ID Numbers:
    • A2341003
    First Posted:
    Apr 21, 2008
    Last Update Posted:
    Sep 8, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide
    Bioequivalence, diphenhydramine hydrochloride
    Additional relevant MeSH terms:
    Diphenhydramine
    Promethazine

    Study Results

    No Results Posted as of Sep 8, 2011