The purpose of this study is evaluate the safety and tolerability parameters regarding the new drug in healthy men and evaluate the pharmacokinetics parameters after one dose and multiple doses of the new drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
22
ACH15 50mg capsule
ACH15 250mg capsule
ACH15 500 mg capsule
ICF - Instituto de Ciências Farmacêuticas
Aparecida de Goiânia, Goiás, Brazil
Blood pressure
Time frame: 30 days
Electrocardiogram
Time frame: 30 days
Echocardiography (participants included in Group 6)
Time frame: 30 days
Cmax
Blood analysis to evaluate drug pharmacokinetics at Group 1 to 5: 30 minutes and 05 minutes before dose and 00h10 min, 00h15 min, 00h30 min, 00h45 min, 01h, 01h15min, 01h30min, 01h45min, 02h, 02h15min, 02h30min, 02h45min, 03h, 03h15min, 03h30min, 03h45min, 04 h, 04h15min, 04h30min, 04h45min, 05h, 05h30min, 06 h, 08 h, 10 h, 12h, 16h, 24 h e 48hours post-dose
Time frame: 31 time points up to 2 days
High digestive endoscopy (participants included at Group 6)
Image exam to evaluate the drug safety
Time frame: 8 days
Blood analysis
Blood will be collected to evaluate the drug safety by analysis of biochemical profile
Time frame: 30 days
Cmax
Blood analysis to evaluate drug pharmacokinetics at Group 6:00:30 min before dose, 00h20min, 00h40min, 01h, 01h15min, 01h30min, 01h45min, 02h, 02h15min, 02h30min, 02h45min, 03h, 03h15min, 03h30min, 03h45min, 04h, 04h15min, 04h30min, 04h45min, 05h, 05h30min, 06h, 08h, 10h, 12h, 14h, 18h, 24h, 26h, 30h, 36h, 38h, 42h, 48h, 50h, 54h, 60h, 62h, 66h, 72h, 74h, 78h, 84h, 86h, 90h, 96h, 98h, 102h, 108h, 110h, 114h, 120h, 122h, 126h, 132h, 134h, 138h, 144h, 146h, 150h, 156h, 158h, 162h, 168h, 174h, 180h e 192h post-dose.
Time frame: 67 pint time over 8 days
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ACH15 500mg capsule - two 500mg capsules in single dose
ACH15 500mg capsule (four 500mg capsules in one dose)
ACH15 - 500mg twice a day for 7 days
Capsule manufactured to mimic ACH15 250 mg capsule
Capsule manufactured to mimic ACH15 500 mg capsule
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)