Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers (NTC00940472)

Laboratorios Silanes

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Step A: metformin glycinate 620 mg single dose; Drug: Step A: metformin glycinate 1240 mg single dose; Drug: Step A: metformin glycinate 1240 mg,food intake; Drug: Step A: metformin hydrochloride 1000 mg single dose; Drug: Step B: metformin hydrochloride 500 mg BID; Drug: Step A: metformin glycinate 2480 mg single dose; Drug: Step B: metformin glycinate 620 mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01560481

NTC00940472

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 7 patient groups

Step A: metformin glycinate 620 mg

Experimental group

Description:

620mg single dose by mouth

Treatment:

Drug: Step A: metformin glycinate 620 mg single dose

Step A: metformin glycinate 1240 mg

Experimental group

Description:

1240mg single dose by mouth

Treatment:

Drug: Step A: metformin glycinate 1240 mg single dose

Step A: metformin glycinate 2480 mg

Experimental group

Description:

2480mg single dose by mouth

Treatment:

Drug: Step A: metformin glycinate 2480 mg single dose

Step A: metformin hydrochloride 1000 mg

Active Comparator group

Description:

1000mg single dose by mouth

Treatment:

Drug: Step A: metformin hydrochloride 1000 mg single dose

Step A: metformin glycinate 1240 mg, food intake

Experimental group

Description:

1240mg single dose by mouth after food intake

Treatment:

Drug: Step A: metformin glycinate 1240 mg,food intake

Step B: metformin glycinate 620 mg BID

Experimental group

Description:

620mg BID for 8 days

Treatment:

Drug: Step B: metformin glycinate 620 mg BID

Step B: metformin hydrochloride 500 mg BID

Active Comparator group

Description:

500mg tablets BID for 8 days

Treatment:

Drug: Step B: metformin hydrochloride 500 mg BID