Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

Nasal Congestion Clinical Trial

Official title:

A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662337
• Other study ID #: A2341003
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2008
• Last updated: September 7, 2011
• Start date: October 2006
• Est. completion date: November 2006

Study information

• Verified date: September 2011
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nasal Congestion

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No