Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride - Full Text View

Sponsor:	Johnson & Johnson Consumer & Personal Products Worldwide
Information provided by (Responsible Party):	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00662337

Purpose

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

Condition	Intervention	Phase
Nasal Congestion	Drug: Diphenhydramine hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Diphenhydramine citrate Diphenhydramine hydrochloride

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer & Personal Products Worldwide:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	October 2006
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662337

Sponsors and Collaborators

Johnson & Johnson Consumer & Personal Products Worldwide

Investigators

Study Director:

Melissa Israel, BS

McNeil Consumer Healthcare Division of McNeil-PPC, Inc.

More Information

No publications provided

Responsible Party:	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00662337 History of Changes
Other Study ID Numbers:	A2341003
Study First Received:	March 20, 2008
Last Updated:	September 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer & Personal Products Worldwide:

Bioequivalence, diphenhydramine hydrochloride

Additional relevant MeSH terms:

Diphenhydramine
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists

Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012