A Bioequivalence Study of RTA 402 5 mg Tablets and 5 mg Capsules Under Fed Condition

JRCT ID: jRCT2051230060

Registered date:01/07/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetic kidney disease
• Date of first enrollment: 02/06/2021
• Target sample size: 70
• Study type: Interventional

Intervention(s)

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 capsules (standard formulation) of RTA 402 under postprandial administration conditions in an open-label, 2-drug x 2-period crossover fashion.
- Screening period: The screening period was from obtaining consent to prior to administration of the study drug in Phase I. Pre-testing was conducted from 28 days (Day -28) to 4 days (Day -4) prior to the administration of the study drug in Phase I.
- Period I and Period II: From Day 1 to the time of discharge on Day 5, respectively, RTA 402 15 mg was administered orally as a single dose on Day 1 (administration period: 2 days in total). In both Phase I and Phase II, subjects entered on Day -3, underwent the prescribed examination, and exited on Day 5.
- Drug withdrawal period: From the time of discharge in Period I to the time before the administration of the study drug in Period II. Day 1 of Period II was 12 days after Day 1 of Period I.

Outcome(s)

• Primary Outcome: Cmax, AUC0-t
• Secondary Outcome: tmax, AUC0-inf, t1/2, MRT, kel

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Mukai Kazuya