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

Laboratorios Silanes S.A. de C.V.49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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: * adverse events, * systolic and diastolic blood pressure, pulse rate and temperature * pulse rate and ECG alterations * alterations in haematology, plasma chemistry, and urine analyses

Time frame: 35 days

Step B: Number of Adverse Events of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days

Tolerability: * adverse events, * systolic and diastolic blood pressure, pulse rate and temperature * pulse rate and ECG alterations * alterations in haematology, plasma chemistry, and urine analyses

Time frame: 25 days

Secondary Outcomes

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.

Time frame: 36 hours

Step A: Linear and dose-proportional (AUC) pharmacokinetic of 620 mg, 1240 mg and 2480 strengths of metformin glycinate

Time frame: 36 hours

Step A: Bioavailability (AUC) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast

Time frame: 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.

Time frame: 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.

Time frame: 8 days

Step B: Pharmacokinetic profile (AUC) of metformin glycinate 620mg BID after administration of multiple doses during 8 days

Time frame: 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.

Time frame: 36 hours

Step A: Linear and dose-proportional pharmacokinetic (Cmax) of 620 mg, 1240 mg and 2480 strengths of metformin glycinate

Time frame: 36 hours

Step A: Bioavailability (Cmax) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast

Time frame: 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.

Time frame: 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.

Time frame: 8 days

Step B: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg BID after administration of multiple doses during 8 days

Time frame: 8 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes