Healthy Adult Male Subjects
Conditions
Brief summary
An open-label, single-center, crossover study to evaluate the impact of administration timing of TS-172 on the pharmacodynamics in healthy adult male subjects.
Interventions
DRUGTS-172
Oral administration of TS-172 20 mg immediately before meal
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. Japanese healthy adult males whose age is \>=18 and \<40 years at the time of obtaining informed consent 2. Subjects whose body mass index is \>=18.5 and \<25.0 at the screening test 3. Subjects who are judged by a principal investigator or a sub-investigator to be eligible for participation in the study based on the results at the screening test and before administration of the drugs used in the study 4. Subjects who have been informed of the clinical trial, understand the details of the trial, and give their written consent prior to participation in the trial
Exclusion criteria
1. Subjects with medical history ineligible for participation in the study such as of respiratory, cardiovascular, gastrointestinal, hepatic, renal, urologic, endocrine, metabolic, hematologic, immunologic, dermatologic, neurologic, or psychiatric diseases 2. Subjects with medical history of disease (e.g., stomach or intestinal ulcers) or surgery (e.g., gastrectomy, gastric bandage, gastric bypass) that may affect the absorption of the drugs used in the study 3. Subjects who have been hospitalized with any treatment or undergone surgery within 12 weeks prior to receiving the drugs used in the study 4. Subjects with medical history of drug allergies (limited to severe symptoms such as anaphylaxis) or significant allergic predispositions (e.g., asthma that requires treatment) 5. Subjects who have used medications (including over-the-counter drugs) within 2 weeks prior to receiving the drugs used in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinaly excretion of phosphorus | Up to 3 days postdose during each period |
| Urinaly excretion of sodium | Up to 3 days postdose during each period |
Countries
Japan
Outcome results
None listed