Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions

NCT ID: NCT03452306

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2017-07-22

Brief Summary

Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Long Merck )

Detailed Description

Study to evaluate the bioequivalence of orally administered metformin preparations, Extended release tablets, 750 mg in normal healthy subjects under fasting and fed conditions

Conditions

Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Metformin

First aIntervention Period:

Single administered dose of Metformin (750 mg tablet extended-release in a fasting condition

Third Intervention Period:

Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition

Group Type: EXPERIMENTAL

Metformine

Intervention Type: DRUG

First aIntervention Period:

Single administered dose of Metformin (750 mg tablet extended-release) in a fasting condition

Metformin

Intervention Type: DRUG

Third Intervention Period:

Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition

Glucophage® Long

Second Intervention Period:

Single administered dose of Glucophage® ( 750 mg tablet extended-release) in a fasting condition

Fourth Intervention Period:

Single administered dose of Glucophage® ( 750 mg tablet extended-release) in a fed condition

Group Type: ACTIVE_COMPARATOR

Glucophage® Long

Intervention Type: DRUG

Second Intervention Period:

Single administered dose of Glucophage® (750 mg tablet extended-release) in a fasting condition

Glucophage® Long

Intervention Type: DRUG

Fourth Intervention Period:

Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition

Interventions

Metformine

First aIntervention Period:

Single administered dose of Metformin (750 mg tablet extended-release) in a fasting condition

Intervention Type: DRUG

Glucophage® Long

Second Intervention Period:

Single administered dose of Glucophage® (750 mg tablet extended-release) in a fasting condition

Intervention Type: DRUG

Metformin

Third Intervention Period:

Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition

Intervention Type: DRUG

Glucophage® Long

Fourth Intervention Period:

Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition

Intervention Type: DRUG

Other Intervention Names

fasting condition; fasting condition; fed condition; fed condition

Eligibility Criteria

Inclusion Criteria

• Signed informed consent form.
• Healthy male and female subjects aged 18 to 45 years.
• Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
• Have a body mass index between 18,5 and 27 kg/m2.
• Females must have a negative pregnancy test.
• Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.

Exclusion Criteria

• History of serious allergic problems/events
• Medicinal intolerance.
• History of allergic reactions to memantine or investigator's product components
• Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
• Acute infectious diseases in less than 4 weeks before the start of the study.
• Subjects who have taken medication 4 weeks preceding before the study.
• Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
• Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
• History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
• Smokers.
• Participation in other clinical training is less than than for 3 months before the study.
• Lack of signed informed consent form.
• ECG or vital signs abnormalities (clinically significant).
• Positive testing for alcohol, drugs, pregnancy.
• Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
• Any diet, for example, vegetarian, for 2 weeks before taking the study medications.
• Women with preserved reproductive potential who have unprotected sexual intercourse with an unsterilized male partner within 30 days prior to taking the study medication.
• Heart rate below 60 or above 80 beats per minute.
• Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.
• Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geropharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yarosslavl Clinical Hospital #3

Yaroslavl, , Russia

Countries

Russia

Other Identifiers

BIOMET-LONG

Identifier Type: -

Identifier Source: org_study_id