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

Healthy Clinical Trial

— NTC00940472  

Official title:

Randomized Clinical Trial to Evaluate Safety, Tolerability and PK-PD Profile of Metformin Glycinate 620 mg,1240 mg, 2480 mg and Metformin Chlorhydrate 1000 mg of One Single Dose, Multiple Dose and After Food Intake.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560481
• Other study ID #: NTC00940472
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2012
• Last updated: January 26, 2018
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2018
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Step A: metformin glycinate 620 mg single dose
metformin glycinate 620 mg single dose
• Step A: metformin glycinate 1240 mg single dose
metformin glycinate 1240 mg single dose
• Step A: metformin glycinate 2480 mg single dose
metformin glycinate 2480 mg single dose
• Step A: metformin hydrochloride 1000 mg single dose
metformin Chlorhydrate 1000 mg single dose
• Step A: metformin glycinate 1240 mg,food intake
metformin glycinate 1240 mg, intake of food
• Step B: metformin glycinate 620 mg BID
metformin glycinate 620 mg BID, 8 days
• Step B: metformin hydrochloride 500 mg BID
metformin Chlorhydrate 500 mg BID, 8 days

Locations

Country	Name	City	State
Spain	Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	35 days
Primary	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	25 days
Secondary	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
Secondary	Step A: Linear and dose-proportional (AUC) pharmacokinetic of 620 mg, 1240 mg and 2480 strengths of metformin glycinate		36 hours
Secondary	Step A: Bioavailability (AUC) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast		36 hours
Secondary	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
Secondary	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
Secondary	Step B: Pharmacokinetic profile (AUC) of metformin glycinate 620mg BID after administration of multiple doses during 8 days		8 days
Secondary	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
Secondary	Step A: Linear and dose-proportional pharmacokinetic (Cmax) of 620 mg, 1240 mg and 2480 strengths of metformin glycinate		36 hours
Secondary	Step A: Bioavailability (Cmax) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast		36 hours
Secondary	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
Secondary	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
Secondary	Step B: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg BID after administration of multiple doses during 8 days		8 days