drugset / Trial / NCT01560481
Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2011-12
- Primary completion
- 2012-03
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Metformin | Small molecule | 620 mg | Oral |
| Subject | Metformin | Small molecule | 1000 mg | Oral |
| Subject | Metformin | Small molecule | 1240 mg | Oral |
| Subject | Metformin | Small molecule | 2480 mg | Oral |
Indications
No indication recorded.