NCT01560481View on ClinicalTrials.gov

Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2013

Conditions
Healthy
Interventions
DRUG

Step A: metformin glycinate 620 mg single dose

metformin glycinate 620 mg single dose

DRUG

Step A: metformin glycinate 1240 mg single dose

metformin glycinate 1240 mg single dose

DRUG

Step A: metformin glycinate 2480 mg single dose

metformin glycinate 2480 mg single dose

DRUG

Step A: metformin hydrochloride 1000 mg single dose

metformin Chlorhydrate 1000 mg single dose

DRUG

Step A: metformin glycinate 1240 mg,food intake

metformin glycinate 1240 mg, intake of food

DRUG

Step B: metformin glycinate 620 mg BID

metformin glycinate 620 mg BID, 8 days

DRUG

Step B: metformin hydrochloride 500 mg BID

metformin Chlorhydrate 500 mg BID, 8 days

Trial Locations (1)

08025

Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau, Barcelona

All Listed Sponsors
lead

Laboratorios Silanes S.A. de C.V.

INDUSTRY

NCT01560481 - Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers | Biotech Hunter | Biotech Hunter