NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071200037

Registered date:05/10/2020

A Bioequivalence Study of enarodustat tablet

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedhealthy volunteers
Date of first enrollment06/10/2020
Target sample size52
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A single oral administration of enarodustat current and new drug products, respectively

Outcome(s)

Primary OutcomeTo evaluate the bioequivalence of enarodustat following single dose of oral administration of new drug product and current drug product
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 45age old
GenderMale
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Ryosuke Koretomo
Address 4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, Japan Tokyo Japan 103-0023
Telephone +81-120-404-611
E-mail clinicaltrials-info-r@jt.com
Affiliation Japan Tobacco Inc.
Scientific contact
Name Ryosuke Koretomo
Address 4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, Japan Tokyo Japan 103-0023
Telephone +81-120-404-611
E-mail clinicaltrials-info-r@jt.com
Affiliation Japan Tobacco Inc.