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

Information source: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

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

Phase: Phase 1

Status: Completed

Sponsored by: Laboratorios Silanes S.A. de C.V.

Official(s) and/or principal investigator(s):
Rosa M Antonijoan, MD, Study Chair, Affiliation: Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau

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.

Clinical Details

Official title: Open Crossover Randomized Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic-pharmacodynamic Profile of Metformin Glycinate 620 mg,1240 mg, 2480 mg and Metformin Chlorhydrate 1000 mg After Administration of One Single Dose, Multiple Dose and After Food Intake in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Step A: Number of Adverse Events of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose

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

Secondary outcome:

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.

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

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

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.

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.

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

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

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

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.

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.

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

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau, Barcelona 08025, Spain
Additional Information

Starting date: December 2011
Last updated: February 12, 2014

Page last updated: August 23, 2015

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