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

NCT01560481 | Completed Phase 1

• 1 other identifier: NTC00940472
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

metformin glycinate; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• 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

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

  36 hours

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

  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.

  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.

  8 days

Study Arms (7)

Step A: metformin glycinate 620 mg

EXPERIMENTAL

620mg single dose by mouth

Drug: Step A: metformin glycinate 620 mg single dose

Step A: metformin glycinate 1240 mg

EXPERIMENTAL

1240mg single dose by mouth

Drug: Step A: metformin glycinate 1240 mg single dose

Step A: metformin glycinate 2480 mg

EXPERIMENTAL

2480mg single dose by mouth

Drug: Step A: metformin glycinate 2480 mg single dose

Step A: metformin hydrochloride 1000 mg

ACTIVE COMPARATOR

1000mg single dose by mouth

Drug: Step A: metformin hydrochloride 1000 mg single dose

Step A: metformin glycinate 1240 mg, food intake

EXPERIMENTAL

1240mg single dose by mouth after food intake

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

Step B: metformin glycinate 620 mg BID

EXPERIMENTAL

620mg BID for 8 days

Drug: Step B: metformin glycinate 620 mg BID

Step B: metformin hydrochloride 500 mg BID

ACTIVE COMPARATOR

500mg tablets BID for 8 days

Drug: Step B: metformin hydrochloride 500 mg BID

Interventions

Step A: metformin glycinate 620 mg single dose DRUG

metformin glycinate 620 mg single dose

Step A: metformin glycinate 620 mg

Step A: metformin glycinate 1240 mg single dose DRUG

metformin glycinate 1240 mg single dose

Step A: metformin glycinate 1240 mg

Step A: metformin glycinate 2480 mg single dose DRUG

metformin glycinate 2480 mg single dose

Step A: metformin glycinate 2480 mg

Step A: metformin hydrochloride 1000 mg single dose DRUG

metformin Chlorhydrate 1000 mg single dose

Step A: metformin hydrochloride 1000 mg

Step A: metformin glycinate 1240 mg,food intake DRUG

metformin glycinate 1240 mg, intake of food

Step A: metformin glycinate 1240 mg, food intake

Step B: metformin glycinate 620 mg BID DRUG

metformin glycinate 620 mg BID, 8 days

Step B: metformin glycinate 620 mg BID

Step B: metformin hydrochloride 500 mg BID DRUG

metformin Chlorhydrate 500 mg BID, 8 days

Step B: metformin hydrochloride 500 mg BID

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

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

Barcelona, 08025, Spain

Location

MeSH Terms

Interventions

Eating; BID protein, human

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Rosa M Antonijoan, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: March 22, 2012
• Study Start: December 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2013
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

ES (1)