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Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

NCT00662337 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-09-08

No results posted yet for this study

Summary

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

Conditions

  • Nasal Congestion

Interventions

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.

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Melissa Israel, BS · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2006-11-30
Completion
2006-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662337 on ClinicalTrials.gov