Nasal Congestion Clinical Trial
Official title:
A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule
The purpose of this study is to determine if two formulations of diphenhydramine hydrochloride are bioequivalent.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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