Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

Johnson & Johnson Consumer and Personal Products Worldwide36 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Nasal Congestion

Interventions

Diphenhydramine hydrochlorideDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.