Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride
Summary
The purpose of this study is to determine if two formulations of diphenhydramine hydrochloride are bioequivalent.
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Conditions
Nasal Congestion
Intervention
Diphenhydramine hydrochloride
Status
Completed
Source
Johnson & Johnson Consumer & Personal Products Worldwide
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00662337
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Oxymetazoline
A direct acting sympathomimetic used as a vasoconstrictor to relieve nasal congestion. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1251)
Synephrine
Sympathetic alpha-adrenergic agonist with actions like PHENYLEPHRINE. It is used as a vasoconstrictor in circulatory failure, asthma, nasal congestion, and glaucoma.
Nasal Lavage Fluid
Fluid obtained by irrigation or washout of the nasal cavity and NASAL MUCOSA. The resulting fluid is used in cytologic and immunologic assays of the nasal mucosa such as with the NASAL PROVOCATION TEST in the diagnosis of nasal hypersensitivity.
Rhinitis, Vasomotor
A form of non-allergic rhinitis that is characterized by nasal congestion and posterior pharyngeal drainage.
Common Cold
A catarrhal disorder of the upper respiratory tract, which may be viral or a mixed infection. It generally involves a runny nose, nasal congestion, and sneezing.
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