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Sponsored by: |
Johnson & Johnson Consumer & Personal Products Worldwide |
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Information provided by: | Johnson & Johnson Consumer & Personal Products Worldwide |
ClinicalTrials.gov Identifier: | NCT00662337 |
The purpose of this study is to determine if two formulations of diphenhydramine hydrochloride are bioequivalent.
Condition | Intervention | Phase |
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Nasal Congestion |
Drug: Diphenhydramine hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule |
Enrollment: | 36 |
Study Start Date: | October 2006 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Diphenydramine HCl
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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.
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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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | JJCPPW ( Joyce Hauze/Senior Project Manager ) |
Study ID Numbers: | A2341003 |
Study First Received: | March 20, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00662337 |
Health Authority: | United States: Institutional Review Board |
Bioequivalence, diphenhydramine hydrochloride |
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