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

NCT ID: NCT01560481

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Step A: metformin glycinate 620 mg

620mg single dose by mouth

Group Type: EXPERIMENTAL

Step A: metformin glycinate 620 mg single dose

Intervention Type: DRUG

metformin glycinate 620 mg single dose

Step A: metformin glycinate 1240 mg

1240mg single dose by mouth

Group Type: EXPERIMENTAL

Step A: metformin glycinate 1240 mg single dose

Intervention Type: DRUG

metformin glycinate 1240 mg single dose

Step A: metformin glycinate 2480 mg

2480mg single dose by mouth

Group Type: EXPERIMENTAL

Step A: metformin glycinate 2480 mg single dose

Intervention Type: DRUG

metformin glycinate 2480 mg single dose

Step A: metformin hydrochloride 1000 mg

1000mg single dose by mouth

Group Type: ACTIVE_COMPARATOR

Step A: metformin hydrochloride 1000 mg single dose

Intervention Type: DRUG

metformin Chlorhydrate 1000 mg single dose

Step A: metformin glycinate 1240 mg, food intake

1240mg single dose by mouth after food intake

Group Type: EXPERIMENTAL

Step A: metformin glycinate 1240 mg,food intake

Intervention Type: DRUG

metformin glycinate 1240 mg, intake of food

Step B: metformin glycinate 620 mg BID

620mg BID for 8 days

Group Type: EXPERIMENTAL

Step B: metformin glycinate 620 mg BID

Intervention Type: DRUG

metformin glycinate 620 mg BID, 8 days

Step B: metformin hydrochloride 500 mg BID

500mg tablets BID for 8 days

Group Type: ACTIVE_COMPARATOR

Step B: metformin hydrochloride 500 mg BID

Intervention Type: DRUG

metformin Chlorhydrate 500 mg BID, 8 days

Interventions

Step A: metformin glycinate 620 mg single dose

metformin glycinate 620 mg single dose

Intervention Type: DRUG

Step A: metformin glycinate 1240 mg single dose

metformin glycinate 1240 mg single dose

Intervention Type: DRUG

Step A: metformin glycinate 2480 mg single dose

metformin glycinate 2480 mg single dose

Intervention Type: DRUG

Step A: metformin hydrochloride 1000 mg single dose

metformin Chlorhydrate 1000 mg single dose

Intervention Type: DRUG

Step A: metformin glycinate 1240 mg,food intake

metformin glycinate 1240 mg, intake of food

Intervention Type: DRUG

Step B: metformin glycinate 620 mg BID

metformin glycinate 620 mg BID, 8 days

Intervention Type: DRUG

Step B: metformin hydrochloride 500 mg BID

metformin Chlorhydrate 500 mg BID, 8 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 45 years.
• Weight within normal ranges (Quetelet index between 21 and 26) (weight (kg)/height (m2).
• Adequate physical examination and clinical history
• No organic and psychiatric disorder
• Normal Blood pressure, Pulse Rate, temperature and ECG.
• Lab test within normal values according to reference lab values of Biochemistry lab of Hospital Santa Creu I Sant Pau. It will be allowed changes according to clinical criteria of the clinical staff of ICIM-SANT PAU
• Females of childbearing potential with adequate contraceptive precautions, other than oral contraceptives and negative urine pregnancy test.
• No participation in any other clinical trial within the previous two months before the initiation of this study.
• No blood donation within the previous four weeks before the initiation of this study.
• Signed informed consent.

Exclusion Criteria

• Drugs or alcohol abuse.
• Consumer of stimulant drinks (> 5 coffees, teas, cola drinks).
• Smokers (> 10 cigars).
• Precedents of drugs allergy or hypersensitivity
• Intake of any other medication within the previous 15 days before this study.
• Positive HIV, HBV or HCV.
• Chronic disease (cardiovascular, respiratory, endocrine, gastrointestinal, hematologic, neurologic or others).
• Prior surgery within the previous six months before the initiation of this study.
• Pregnant women or breastfeeding or females of childbearing potential with no adequate contraceptive precautions, other than oral contraceptives.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Silanes S.A. de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosa M Antonijoan, MD

Role: STUDY_CHAIR

Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau

Locations

Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Spain

Other Identifiers

NTC00940472

Identifier Type: -

Identifier Source: org_study_id