Healthy adult male
Conditions
Sponsors
Otsuka Pharmaceutical Co., LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Body mass index [BMI = body weight in kg /(height in m)2] of at least 18.5 kg/m2 and less than 25.0 kg/m2 (as a result of at the screening examination) 2.Capable of providing written informed consent before commencement of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial.
Exclusion criteria
Exclusion criteria: 1.Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator, subinvestigator, or sponsor may place the subject at risk or interfere with outcome variables such as drug absorption, distribution, metabolism, and excretion 2.History of serious mental disorder 3.History of drug or alcohol abuse within 2 years prior to screening 4.History of any significant drug allergy 5.Use of another investigational drug within 120 days prior to the first administration of IMP 6.Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, star fruit, or star fruit products within 72 hours prior to the first administration of IMP or consumption of alcohol within 72 hours prior to administration of IMP. 7.Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin supplements, or consumption of food or beverages containing St. John's Wort within 14 days prior to the first administration of IMP, or use of antibiotics within 30 days prior to the first administration of IMP. 8.History of major surgery of the digestive tract (excluding appendectomy) 9.Any subject who, in the judgement of the investigator or subinvestigator, should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bioequivalence Cmax, AUCt | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics 1.Plasma concentration-time profiles 2.AUC, tmax, AUC_%Extrap, t1/2, CL/F, CL/F/BW, tlast | — |
Countries
Japan
Outcome results
None listed