Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

Sponsor
Chipscreen Biosciences, Ltd.
Study ID
NCT05681273
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Chiglitazar — DRUG
    Chiglitazar 48mg
  • Empagliflozin — DRUG
    Empagliflozin 10mg
  • Atorvastatin — DRUG
    Atorvastatin 20mg
  • Valsartan — DRUG
    Valsartan 160mg

Study Details

This Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and safety profiles of Chiglitazar with Empagliflozin，Atorvastatin and Valsartan in healthy subjects.

Key Dates

Start date
Feb 17, 2023
Status verified
Dec 2022
Primary completion
Mar 21, 2023
Completion
Mar 21, 2023

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    D1: Oral single dose of Empagliflozin 10 mg; D5\~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Empagliflozin 10 mg and Chiglitazar 48 mg.
  • Experimental: Group B
    D1: Oral single dose of Atorvastatin 20 mg; D5\~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Atorvastatin 20 mg and Chiglitazar 48 mg.
  • Experimental: Group C
    D1: Oral single dose of Valsartan 160 mg; D5\~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Valsartan 160 mg and Chiglitazar 48 mg.

Primary Outcome Measure

Cmax [ Time Frame: up to 72 hours ]

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