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Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00662337
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : September 8, 2011
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Description
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Brief Summary:
The purpose of this study is to determine if two formulations of diphenhydramine hydrochloride are bioequivalent.

Condition or disease Intervention/treatment Phase
Nasal Congestion 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
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Study Type : Interventional  (Clinical Trial)
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 : October 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUC0-t and AUC0-infinity [ Time Frame: 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. [ Time Frame: 15 minutes pre-dose (0 hour) through 28 days post-dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662337


Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
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Study Director: Melissa Israel, BS McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
More Information
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Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00662337    
Other Study ID Numbers: A2341003
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Bioequivalence, diphenhydramine hydrochloride
Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
 Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents