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

NCT01560481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-01-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Rosa M Antonijoan, MD · Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-03-31
Completion
2013-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01560481 on ClinicalTrials.gov