NCT04841720

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

Phase I Clinical Study to Evaluate the Drug-drug Interaction Between HSK16149 Capsules and Metformin Hydrochloride Tablets in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed description

All subjects received the following drugs: Phase 1-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); Phase 2-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); 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.

Conditions

• Diabetic Neuropathies
• Diabetic Neuropathy Peripheral

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-06-30
• Completion: 2021-08-15
• First posted: 2021-04-12
• Last updated: 2021-04-12

Locations

1 site across 1 country: China