The Relative Bioavailability and Dose Linearity of Budesonide in Healthy Adult Japanese and Non-Asian Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071240012

Enrollment

Registered

2024-05-16

Start date

2024-05-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary immunoglobulin A nephropathy (IgAN)

Interventions

Subjects will be housed the day prior dosing and until at least 36 hours after dosing. There will be 2 periods and at each period, a single, oral 8 mg (2 * 4 mg) or 16 mg (4 * 4 mg) dose of study medi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. Japanese: Subjects born from Japanese parents and grandparents. If not living in Japan, must be less than 10 years from primary residence in Japan with no significant lifestyle changes, including diet or eating habits, since leaving Japan. b. Non-Asian: Subjects with parents and grandparents of non-Asian ancestry (e.g., born in the US/Australia/Canada/New Zealand/western or eastern Europe). No more than 6 individuals of Hispanic origin are permitted to participate. If living in Japan, must be less than 10 years from primary residence in their country of origin with no significant lifestyle changes, including diet or eating habits, since moving to Japan.

Exclusion criteria

Exclusion criteria: Individuals of African/black, Asian, or pacific islander heritage are not eligible to be part of the non-Asian group. Social Habits: a. Use of any tobacco/nicotine-containing product within 6 months of the start of the study. b. Ingestion of any alcoholic beverage within the 48 hours prior to the initial administration of study medication. c. Ingestion of any caffeine- or xanthine-containing food or beverage within the 24 hours prior to the initial administration of study medication. d. Ingestion of any vitamins or herbal products within 7 days prior to the initial administration of the study medication. e. Any recent, significant change in dietary or exercise habits. f. History of drug and/or alcohol abuse within one year of start of study.

Design outcomes

Primary

Measure	Time frame
The relative bioavailability of VR-205 (budesonide) delayed release capsules 4 mg in Japanese and non-Asian will be determined by a comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves (e.g., AUCL, AUCINF, and CPEAK) of budesonide.	—

Contacts

Public ContactjRCT Inquiry Contact IQVIA Services Japan G.K.

IQVIA Services Japan G.K

masato.kamimoto@iqvia.com+81-3-6859-9500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026