Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 11, 2018

Primary Completion Date

November 22, 2018

Study Completion Date

January 30, 2019

Conditions
Healthy Volunteers
Interventions
DRUG

Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg)

"Subjects were allocated to one of two groups randomly and equally with a 3-day washout interval between the two periods.Cefprozil for Suspension® (125mg/5mL, 50mL/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.) and cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study."

Trial Locations (1)

266003

Phase I Clinical Research Center, Qingdao

All Listed Sponsors
lead

The Affiliated Hospital of Qingdao University

OTHER

NCT04414254 - Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers | Biotech Hunter | Biotech Hunter