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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step A: metformin glycinate 620 mg | Experimental | 620mg single dose by mouth |
|
| Step A: metformin glycinate 1240 mg | Experimental | 1240mg single dose by mouth |
|
| Step A: metformin glycinate 2480 mg | Experimental | 2480mg single dose by mouth |
|
| Step A: metformin hydrochloride 1000 mg | Active Comparator | 1000mg single dose by mouth |
|
| Step A: metformin glycinate 1240 mg, food intake | Experimental | 1240mg single dose by mouth after food intake |
|
| Step B: metformin glycinate 620 mg BID | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Step A: metformin glycinate 620 mg single dose | Drug | metformin glycinate 620 mg single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Step A: Number of Adverse Events of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose | Tolerability:
| 35 days |
| Step B: Number of Adverse Events of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days | Tolerability:
| 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Step A: Bioavailability (AUC) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD. | 36 hours | |
| Step A: Linear and dose-proportional (AUC) pharmacokinetic of 620 mg, 1240 mg and 2480 strengths of metformin glycinate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa M Antonijoan, MD | Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
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620mg BID for 8 days |
|
| Step B: metformin hydrochloride 500 mg BID | Active Comparator | 500mg tablets BID for 8 days |
|
| Step A: metformin glycinate 1240 mg single dose | Drug | metformin glycinate 1240 mg single dose |
|
| Step A: metformin glycinate 2480 mg single dose | Drug | metformin glycinate 2480 mg single dose |
|
| Step A: metformin hydrochloride 1000 mg single dose | Drug | metformin Chlorhydrate 1000 mg single dose |
|
| Step A: metformin glycinate 1240 mg,food intake | Drug | metformin glycinate 1240 mg, intake of food |
|
| Step B: metformin glycinate 620 mg BID | Drug | metformin glycinate 620 mg BID, 8 days |
|
| Step B: metformin hydrochloride 500 mg BID | Drug | metformin Chlorhydrate 500 mg BID, 8 days |
|
| 36 hours |
| Step A: Bioavailability (AUC) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast | 36 hours |
| Step A: Pharmacokinetic profile (AUC) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD. | 36 hours |
| Step B: Bioavailability (AUC) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days. | 8 days |
| Step B: Pharmacokinetic profile (AUC) of metformin glycinate 620mg BID after administration of multiple doses during 8 days | 8 days |
| Step A: Bioavailability (Cmax) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD. | 36 hours |
| Step A: Linear and dose-proportional pharmacokinetic (Cmax) of 620 mg, 1240 mg and 2480 strengths of metformin glycinate | 36 hours |
| Step A: Bioavailability (Cmax) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast | 36 hours |
| Step A: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD. | 36 hours |
| Step B: Bioavailability (Cmax) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days. | 8 days |
| Step B: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg BID after administration of multiple doses during 8 days | 8 days |
| ID | Term |
|---|---|
| D004435 | Eating |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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