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CompletedNCT06084156Updated Oct 16, 2023

A Study to Evaluate the DDI of HSK7653 With Metformin

A Phase 1 interventional study of HSK7653 and Metformin in Type 2 Diabetes Mellitus, sponsored by Haisco Pharmaceutical Group Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-16.

Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Aug 2019, registered Sep 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 114 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age ≥18 and Age ≤60 years
  • BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index)
  • Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures.

Exclusion criteria

Exclusion Criteria:

  • Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening;
  • Fasting blood glucose \<3.9mmol/L or ≥6.1mmol/L;
  • Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug;
  • Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV);
  • Treatment with an investigational drug within 3 months;
  • Other protocol-defined exclusion criteria.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    HSK7653 and Metformin

    Drug: HSK7653 · Drug: Metformin

Interventions

  • DrugHSK7653

    Part 1: Day 1 to Day 4, not take; Part 2: Day 6 - Take HSK7653 35 mg; HSK7653 25 mg on day 13, day 20, day 27, and day 34; Part 3: Day 41 - Take HSK7653 25 mg

  • DrugMetformin

    Part 1: Day 1 to Day 4, 1000mg BID; Part 2: Not take; Part 3: Day 38- day 47, 1000mg BID

06

What researchers measure

Primary outcomes

  1. The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.

    Time frame: Day4, day 27 and day 41

  2. The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.

    Time frame: Day4, day 27 and day 41

Secondary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: First dose of study drug up to 62 days after last dose of study drug

  2. Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated

    Time frame: Day 41

07

Study locations

1 site
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06084156
Lead sponsor
Haisco Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Oct 16, 2023
Start date
Aug 10, 2019
Primary completion
Dec 9, 2019
Completion
Dec 9, 2019
Last update
Oct 16, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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