Anemia associated with chronic kidney disease
Conditions
Interventions
A single oral administration of new and current drug product, respectively
Sponsors
Koretomo Ryosuke
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The participant is a healthy Japanese adult male, aged 20 to 45 years, inclusive, at the time of informed consent. 2. BMI of at least 18.5 kg/m2 and less than 25.0 kg/m2
Exclusion criteria
Exclusion criteria: 1. Clinically relevant history or current treatment of serious disease such as cerebral, hepatic, renal, cardiac, pulmonary, gastrointestinal, hematological, endocrine, metabolic or psychiatric disease 2. Found to meet protocol-defined conditions determined by screening results (e.g., laboratory tests, vital sign) 3. Positive SARS-CoV-2 test result 4. History of gestrointestinal surgery that would be expected to influence the absorption of drugs. 5. History or presence of any drug allergy 6. History or presence of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the bioequivalence of enarodustat following single dose of oral administration of new drug product and current drug product | — |
Contacts
Public Contactclinical trials information
Shionogi & Co.,Ltd.
Outcome results
None listed