Clinical trial NCT00662337: Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride
Official title: A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nasal Congestion
Keywords: Bioequivalence, diphenhydramine hydrochloride
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUC0-t and AUC0-infinity
timeFrame: 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:
measure: 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.
timeFrame: 15 minutes pre-dose (0 hour) through 28 days post-dose
Other outcomes:
Locations:
Study officials:
affiliation: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
name: Melissa Israel, BS
role: STUDY_DIRECTOR
References: