Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

NCT ID: NCT00662337

Last Updated: 2011-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2006-11-30

Brief Summary

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

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.

Conditions

Nasal Congestion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

Diphenydramine HCl

Group Type: EXPERIMENTAL

Diphenhydramine hydrochloride

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Benadryl Allergy; 25 mg KAPSEALS capsule; 25 mg ULTRATAB tablets

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Israel, BS

Role: STUDY_DIRECTOR

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Other Identifiers

A2341003

Identifier Type: -

Identifier Source: org_study_id