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Completed

NCT Number: NCT01560481

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Step A: metformin glycinate 620 mg single dose

Drug

metformin glycinate 620 mg single dose

Step A: metformin glycinate 1240 mg single dose

Drug

metformin glycinate 1240 mg single dose

Step A: metformin glycinate 2480 mg single dose

Drug

metformin glycinate 2480 mg single dose

Step A: metformin hydrochloride 1000 mg single dose

Drug

metformin Chlorhydrate 1000 mg single dose

Step A: metformin glycinate 1240 mg,food intake

Drug

metformin glycinate 1240 mg, intake of food

Step B: metformin glycinate 620 mg BID

Drug

metformin glycinate 620 mg BID, 8 days

Step B: metformin hydrochloride 500 mg BID

Drug

metformin Chlorhydrate 500 mg BID, 8 days

Primary outcomes

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

    Time frame: 35 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

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

    Time frame: 25 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

Secondary outcomes

  1. 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

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

    Time frame: 36 hours

  3. 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

  4. 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

  5. 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

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

    Time frame: 8 days

  7. 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

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

    Time frame: 36 hours

  9. 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

  10. 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

  11. 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

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

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Laboratorios Silanes S.A. de C.V.

Industry

Registry information

Official study 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.

Acronym: NTC00940472

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 22, 2012
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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