Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
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.