To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal
Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast
SFBC Anapharm
Montreal (Quebec), Canada
Rate and extent of absorption
Time frame: 120 hours (5 days)
Safety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs.
Time frame: signing of informed consent to 30 days after last study visit
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