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A Study Evaluating Drug-Drug Interaction (DDI) Between HSK16149 Capsules and Metformin Hydrochloride Tablets

NCT04841720 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-04-12

No results posted yet for this study

Summary

This study is a single-center, open, single-arm study, conducted in healthy Chinese populations, and plans to enroll 22 healthy adult subjects (the ratio of either sex is not less than 1/3).

Conditions

  • Diabetic Neuropathies
  • Diabetic Neuropathy Peripheral

Interventions

DRUG

HSK16149

HSK16149 capsules for single use: D1-D4 oral HSK16149 capsules 80 mg BID, D5 only oral HSK16149 capsules 80 mg in the morning on an empty stomach; wash-out period is about 4 days (D5-D8);

DRUG

Metformin Hydrochloride tablet

Metformin hydrochloride tablets for single use: D9-D11 oral metformin hydrochloride tablets 500 mg BID, D12 only take 500 mg metformin hydrochloride tablets in the morning on an empty stomach; wash-out period is about 4 days (D12-D15);

DRUG

HSK16149+Metformin（phase 3）

Combined use of HSK16149 capsules and metformin hydrochloride tablets: D16-D19 oral metformin hydrochloride tablets 500 mg BID, D16-D19 oral HSK16149 80 mg BID; D20 oral metformin hydrochloride tablets 500 mg and HSK16149 capsules 80 mg in the morning on an empty stomach.

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mingxia Wang, PhD · Medical Ethics Committee of theThe fourth hospital of Hebei Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-06-30
Completion
2021-08-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841720 on ClinicalTrials.gov