This study is intended to evaluate the PK, safety, and tolerability of balcinrenone/dapagliflozin given as a single dose capsule to healthy Chinese participants.
This is a Phase I, open-label, single-arm, single dose PK study in healthy Chinese participants to be conducted at a single study centre in mainland China. In this study, approximately 10 participants (both females and males) will be assigned to the IMP. Each participant will receive a single dose of a capsule with balcinrenone/dapagliflozin 40 mg/10 mg on Day 1 under fasted condition. The study will comprise of the following: * A screening period * A treatment period * A follow-up visit At the discretion of the investigator, the participant may remain in the study center until the completion of the follow-up visit
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Research Site
Chengdu, China
AUCinf of AUCinf of balcinrenone/dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours
AUClast of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours
Cmax of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours
C24h of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours
tmax of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours
t½λz of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours
λz of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours
CL/F of balcinrenone /dapagliflozin
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To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours
MRTinf of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours
Vz/F of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Time frame: Day 1 to post dose 48 hours