The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
36
Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.
Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings
Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings
Mds Pharma Services (Us) Inc.
Neptune City, New Jersey, United States
To assess the bioavailability of 4 experimental formulations relative to the current reference formulation
Time frame: Day 1, up to 3 weeks
Safety: Adverse Events
Time frame: Day 1, up to 3 weeks
Safety: Vital Signs
Time frame: Screening, Day 1 and Day 4 of each period
Safety: ECGs
Time frame: Screening, Day 1 of each period, up to 3 weeks
Safety: Clinical Lab Tests
Time frame: Screening, Day -1 of each period, Day 1, up to 3 weeks
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Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings
Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings