The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
173
40 mg delayed-release tablet administered orally in the morning of Days 1-7
2.5 mg tablet containing \~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5
2.5 mg tablet containing \~23% API as free base (STANDARD) administered orally on the morning of Day 5
Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348
Time frame: Up to 72 hours after SCH 530348 dose on Day 5
Maximal plasma concentration (Cmax) of SCH 530348
Time frame: Up to 72 hours after SCH 530348 dose on Day 5
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time frame: Up to 2 weeks after last dose
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