A Phase 1 interventional study of Buspirone HCl and Buspirone HCl in To Determine Bioequivalence Under Fed Conditions, sponsored by Par Pharmaceutical, Inc.. Completed at 1 site in Canada. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by Par Pharmaceutical, Inc. · Phase 1, Interventional, and Other
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg buspirone HCl tablets, following administration of a 30 mg dose, under fed conditions. In addition, the bioavailability of the Par product was compared under fed and fasting conditions.
Exclusion Criteria:
Subjects received the Par formulated product under fasting conditions
Drug: Buspirone HCl
Subjects received the Par formulated product under fed conditions
Drug: Buspirone HCl
Subjects received the Bristol-Myers Squibb formulated product under fed conditions
Drug: Buspar
Tablets, 30 mg, single-dose, fasting conditions
Also known as: Buspar
Tablets, 30 mg, single-dose, fed conditions
Also known as: Buspar
Tablets, 30 mg, single-dose, fed conditions
Also known as: Buspirone HCl
Rate and extent of absorption
Time frame: 24 hours
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Par Pharmaceutical, Inc.