NCT01560481

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

Randomized Clinical Trial to Evaluate Safety, Tolerability and PK-PD Profile of Metformin Glycinate 620 mg,1240 mg, 2480 mg and Metformin Chlorhydrate 1000 mg of One Single Dose, Multiple Dose and After Food Intake.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes. The objective of this study is to evaluate the safety, tolerability and pK profile of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose, in step A. In step A will be included 25 volunteers. In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be included 24 volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-03-01
• Completion: 2013-03-01
• First posted: 2012-03-22
• Last updated: 2018-01-30

Locations

1 site across 1 country: Spain