Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00662337

Enrollment

Registered

2008-04-21

Start date

2006-10-31

Completion date

2006-11-30

Last updated

2011-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Congestion

Keywords

Bioequivalence, diphenhydramine hydrochloride

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.

Interventions

DRUGDiphenhydramine 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026