Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Study ID
NCT06654960
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • HRS9531 injection — DRUG
    HRS9531 injection single dose.
  • Metformin Hydrochloride tablets — DRUG
    Metformin Hydrochloride tablets 500mg.

Study Details

The purpose of this study is to evaluate the influence of HRS9531 injection on pharmacokinetics of metformin in healthy subjects.

Key Dates

Start date
Nov 5, 2024
Status verified
Oct 2024
Primary completion
Dec 26, 2024
Completion
Dec 26, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm

Primary Outcome Measure

Area under the concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days. [ Time Frame: Start of treatment up to 12 hours. ]

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