Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

NCT00662337 | Completed Phase 1

• 1 other identifier: A2341003
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Nasal Congestion

Keywords

Bioequivalence, diphenhydramine hydrochloride

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (1)

1

EXPERIMENTAL

Diphenydramine HCl

Drug: Diphenhydramine hydrochloride

Interventions

Diphenhydramine hydrochloride 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.

Also known as: Benadryl Allergy, 25 mg KAPSEALS capsule, 25 mg ULTRATAB tablets

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Diphenhydramine

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Melissa Israel, BS

  McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: April 21, 2008
• Study Start: October 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: September 8, 2011

Record last verified: 2011-09