Diabetic kidney disease
Conditions
Interventions
The study consisted of a screening phase, phase I, a withdrawal phase, and phase II. The study was conducted to verify the bioequivalence of three 5 mg tablets (test formulation) and three 5 mg capsul
Sponsors
Mukai Kazuya
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Written voluntary informed consent to participate in the study. 2) Japanese men 20 to <40 years of age at informed consent. 3) BMI 18.5 kg/m2 to <25.0 kg/m2 at screening.
Exclusion criteria
Exclusion criteria: 1)Presence of any disease requiring treatment. 2)History of heart failure (e.g., history of diagnosis of congestive heart failure categorized as Class III or IV of the New York Heart Association (NYHA) Functional Classification or history of hospitalization due to heart failure). 3)Alcoholism or drug addiction, or any positive result on drug abuse testing. 4)History of or current drug allergy. 5)Any positive result on infectious disease testing. 6)Any drug (including OTC drugs, topical drugs, vitamins, and herbal medicines) used within 2 weeks prior to administration of the investigational drug in Phase I. 7) Consumed grapefruit (including food or drink containing grapefruit) or St. John's wort (including food or drink containing St. John's wort) or any other food or drink that may affect the absorption or metabolism of the investigational drug within 1 week prior to the administration of the investigational drug in Phase I. 8) Smoked or used smoking cessation aids within 2 weeks prior to administration of the investigational drug in Phase I. 9) Participated in a clinical trial of a drug and received an investigational drug within 4 months prior to the administration of the investigational drug in Phase I. 10) Patients who were hospitalized or underwent surgery, or had blood drawn (including blood donation and component blood donation) of 200 mL or more within 3 months prior to the administration of the investigational drug in Phase I. 11) Patients who did not agree to use a highly effective method of contraception from the date of administration of the investigational drug in Phase I to 3 months after the administration of the investigational drug in Phase II. 12) Those who were unable to keep proper records in the subject's diary after the investigator and others checked the records of food and drink consumed from one week prior to admission to Phase I to immediately prior to admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax, AUC0-inf, t1/2, MRT, kel | — |
Contacts
Public ContactClinical trial information contact
Kyowa Kirin Co., Ltd.
Outcome results
None listed