Healthy volunteer
Conditions
Interventions
[Two-drug, Three-stage crossover study]
A single oral dose of KA-2301(2 mg) or ReQuip CR (2 mg) will be administered under fasted conditions, or A single oral dose of KA-2301 (2 mg) after meals.
Sponsors
Tabata Toshiyuki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese males at least 18 years but less than 45 years of age at the time of informed consent 2) Body mass index (BMI) of at least 18.5 but less than 25.0 3) Regarding participation in this clinical study, participant capable of providing written consent by him
Exclusion criteria
Exclusion criteria: 1) Participant who has concomitant or a history of serious gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, or cardiovascular disorders. 2) Participant who has concomitant or a history of neuropsychiatric disorders. 3) Participant who has concomitant or a history of orthostatic hypotension. 4) Participant who has a history of gastrointestinal (excluding appendix), liver, or renal surgery. 5) Participant who has concomitant or a history of drug allergies. 6) Participant who has concomitant or a history of impulse control disorders, including drug dependence, alcohol dependence, or pathological gambling (gambling addiction).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Pharmacokinetic endpoints] Plasma PK parameter [Safety endpoints] 1) Adverse events 2) Laboratory tests (hematology, biochemistry and urinalysis) 3) Vital signs (body temperature, blood pressure, pulse rate) 4) 12-Lead ECG | — |
Contacts
Public ContactPharmaceutical Project Steering Pharmaceutical R&D Division
Alfresa Pharma Corporation
Outcome results
None listed