Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

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

Detailed Description
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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.

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

Conditions
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Nasal Congestion

Intervention / Treatment
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* Drug: Diphenhydramine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Diphenydramine HCl | Drug: Diphenhydramine hydrochloride<br>* 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.<br>* Other names: 25 mg ULTRATAB tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, diphenhydramine hydrochloride