A Bioequivalence Study of enarodustat tablet

JRCT ID: jRCT2071200037

Registered date:05/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Anemia associated with chronic kidney disease
• Date of first enrollment: 06/10/2020
• Target sample size: 52
• Study type: Interventional
• Intervention(s): A single oral administration of enarodustat current and new drug products, respectively

Outcome(s)

• Primary Outcome: To evaluate the bioequivalence of enarodustat following single dose of oral administration of new drug product and current drug product

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include 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

Exclude 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. History of gestrointestinal surgery that would be expected to influence the absorption of drugs.
4. History or presence of any drug allergy
5. History or presence of drug or alcohol abuse

Related Information

• Primary Sponsor: Koretomo Ryosuke
• Source(s) of Monetary Support: Torii Pharmaceutical Co.,Ltd