A Phase I PK Study of Balcinrenone/Dapagliflozin in Healthy Chinese Participants
NCT06651021 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-01-15
Summary
This study is intended to evaluate the PK, safety, and tolerability of balcinrenone/dapagliflozin given as a single dose capsule to healthy Chinese participants.
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
balcinrenone/dapagliflozin
Each participant will receive a single dose of balcinrenone/dapagliflozin 40 mg/10 mg capsule on Day 1 under fasted condition. Each participant will be involved in the study for up to 35 days.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-10-21
- Primary Completion
- 2024-10-28
- Completion
- 2024-10-28
Countries
- China
Study Locations
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