Phase I Study of BM2216 ER vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

January 4, 2025

Study Completion Date

January 12, 2025

Conditions
Diabetic NeuropathiesDiabetes Mellitus
Interventions
DRUG

BM2216 Extended-Release tablets(5.5mg)

5.5mg BM2216 Extended-Release ,test drug

DRUG

Mirogabalin Besilate Tablets

15mg of Mirogabalin Besilate Tablets,reference drug

DRUG

BM2216 Extended-Release Tablets(11mg)

11mg of BM2216 Extended-Release,test drug

DRUG

BM2216 Extended-Release Tablets(16.5mg)

16.5mg of BM2216 Extended-Release Tablets,test drug

Trial Locations (1)

402760

Chongqing Bishan People's Hospital, Chongqing

All Listed Sponsors
lead

Zhejiang Anglikang Pharmaceutical Co., Ltd.

INDUSTRY

NCT06846567 - Phase I Study of BM2216 ER vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults | Biotech Hunter | Biotech Hunter