Healthy
Conditions
Keywords
Safety, Pharmacokinetics, Tolerability, Healthy men
Brief summary
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.
Interventions
DRUGACH15 50 mg
ACH15 50mg capsule
DRUGACH15 250 mg
ACH15 250mg capsule
DRUGACH15 500mg
ACH15 500 mg capsule
DRUGACH15 - 1000mg
ACH15 500mg capsule - two 500mg capsules in single dose
DRUGACH15 - 2000mg
ACH15 500mg capsule (four 500mg capsules in one dose)
DRUGACH15 - 500mg
ACH15 - 500mg twice a day for 7 days
DRUGPlacebo 250 mg
Capsule manufactured to mimic ACH15 250 mg capsule
DRUGPlacebo 500mg
Capsule manufactured to mimic ACH15 500 mg capsule
DRUGPlacebo 1000mg
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)
DRUGPlacebo 2000mg
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)
Sponsors
Ache Laboratorios Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Male patient, aged between 18 and 50 years; * Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and ≤ 30 kg/m2; * Healthy men accordance with their historical and tests; * Healthy subject with laboratory results within the normal range or within the parameters accepted by the clinical protocol * Negative results for parasitological stool examination performed in the clinical study; * Subject of research with laboratory results within the normal range for urinalysis collected before the first visit; * Research subjects allocated in Group 6 with endoscopy within the normal range;
Exclusion criteria
* History of gastrointestinal disease, hepatic, renal, cardiovascular, pulmonary, neurologic, hematologic, diabetes or glaucoma; * Evidence on clinical examination or physical or complement, organ dysfunction or any clinically significant deviation from normality; * History of use of psychotropic drugs or excessive alcohol consumption (more than two units of alcohol per day, one unit being equivalent to one cup (200 mL) of brew or a dose (50) mL of distilled beverage) or having difficulty to abstain during the study; * Use of any medication two (2) weeks prior to inclusion of the research subject in the study; * Regular smokers or who quit less than one (1) year; * History of food allergy or hyperreactivity to medications or foods; * HIV positive for HIV; * Being positive for Hepatitis B; * Being positive for hepatitis C; * Testing positive for Helicobacter pilorum; * Using substances modulating hepatic microsomal activity within thirty (30) days prior to entry of the subject of research in the clinical study (date of signing the consent form); * Having donated blood (blood volume higher than 500 mL) within four (4) months preceding the date of signing the consent form; * Subject with a history of hypersensitivity to any component of the investigational product;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 30 days | — |
| Electrocardiogram | 30 days | — |
| Echocardiography (participants included in Group 6) | 30 days | — |
| Cmax | 31 time points up to 2 days | 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 |
| High digestive endoscopy (participants included at Group 6) | 8 days | Image exam to evaluate the drug safety |
| Blood analysis | 30 days | Blood will be collected to evaluate the drug safety by analysis of biochemical profile |
Countries
Brazil
Outcome results
None listed