- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02217670
Comparative Bioavailability Study of Metformin HCl 1000 mg Granules vs Glucophage 1000 mg Film-coated Tablet
January 19, 2016 updated by: Disphar International B.V.
The main purpose of this study is to assess comparative bioavailability of a test formulation of Metformin HCl 1000 mg granules manufactured by Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of Disphar International B.V., The Netherlands) relative to Glucophage 1000 mg film-coated tablets of Merck GmbH, Austria in 54 healthy adult subjects under fed conditions.
The second aim is to asses the safety of subjects and to determine other pharmacokinetic data.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amman, Jordan
- International Pharmaceutical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 to 50 years, inclusive.
- Body Mass Index (BMI) range is within 18.5 - 30.0 Kg/m2.
- Subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.
Exclusion Criteria:
- Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges.
- Results of laboratory tests which are outside the normal range or HbA1c test or liver or kidney function tests (Creatinine levels and ALP will be accepted if below reference range) that are outside the reference range or Hb or RBC indices (MCV, MCH, MCHC) with deviation outside 5% of the reference range.
- Acute infection within one week preceding first study drug administration.
- History of drug or alcohol abuse.
- Subject is a heavy smoker (more than 10 cigarettes per day).
- Subject does not agree not to take any prescription or non-prescription drugs within the two weeks preceding the first study drug administration until donating the last sample of the study.
- Subject does not agree not to take any vitamins taken for nutritional purposes within two days before first study drug administration until donating the last sample of the study.
- Subject is on a special diet (for example subject is a vegetarian).
- Subject consumes large quantities of alcohol or beverages containing methylxanthines e.g. caffeine (coffee, tea, cola, chocolate etc).
- Subject does not agree not to consume any beverages or food containing alcohol 48 hours prior to study drug administration until donating the last sample in each respective period.
- Subject does not agree not to consume any beverages or food containing methyl-xanthines e.g. caffeine (coffee, tea, cola, chocolate etc.) 24 hours prior to the study drug administration until the end of confinement period.
- Subject does not agree not to consume any beverages or food containing grapefruit 7 days prior to first study drug administration until donating the last sample in the study.
- Subject has a history of severe diseases which have direct impact on the study.
- Participation in a bioequivalence/bioavailability study or in a clinical study within the last 80 days before first study drug administration.
- Subject intends to be hospitalized within 3 months after first study drugs administration.
- Subjects who donated blood or its derivatives in the past 3 months or who through completion of this study, would have donated more than 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
- The female subject is pregnant or lactating.
- Subject has a history of significant asthma, peptic or gastric ulcer, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders, type I diabetes or diabetic ketoacidosis, lactic acidiosis, Vitamin B12 deficiency, psychiatric, dermatologic, immunological disorders or surgery.
- Subject does not agree not to engage in strenuous exercise at least one day prior to study drug administration.
- Subject having at screening examination a pulse outside the normal range of (60-100 beat per minute) or a body temperature outside the normal range of (36.4-37.7 ○C) or a respiratory rate outside the normal range of (14-20 breath per minute) or a sitting blood pressure less than 100/60 mm Hg or more than or equal to 140/90 mm Hg.
- Subject has history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
- Subject undergoing radiologic studies involving intravascular administration of iodinated contrast materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials).
- Fasting blood sugar at screening is less than 70 mg/dl.
- Subject has diabetes mellitus.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin (test)
single oral dose of Metformin 1000 mg granules
|
|
Active Comparator: Metformin (reference)
Single dose of Glucophage 1000 mg film-coated tablet
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC(0-t)
Time Frame: Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
Cmax
Time Frame: Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tmax
Time Frame: Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
AUC(0-inf)
Time Frame: Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
AUCres
Time Frame: Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
t1/2
Time Frame: Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events.
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Anticipated)
January 1, 2016
Study Registration Dates
First Submitted
August 14, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimate)
August 15, 2014
Study Record Updates
Last Update Posted (Estimate)
January 20, 2016
Last Update Submitted That Met QC Criteria
January 19, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METF-GT016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Comparative Bioavailability
-
SocraTec R&D GmbHSocraMetrics GmbH; Glatt Pharmaceutical Services GmbH & Co. KGCompletedComparative BioavailabilityGermany
-
Nordic Pharma, USANutrasource Pharmaceutical and Nutraceutical Services, Inc.CompletedComparative BioavailabilityCanada
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingComparative Bioavailability StudyBangladesh
-
SocraTec R&D GmbHSocraMetrics GmbH; Teikoku Seiyaku Co., Ltd.CompletedComparative BioavailabilityGermany
-
Disphar International B.V.WithdrawnComparative BioavailabilityJordan
-
Hospital Universitario Dr. Jose E. GonzalezTerminatedComparative Bioavailability of Clopidogrel TabletsMexico
-
Faculty of Dental Medicine for GirlsCompletedComparative StudyEgypt
-
The University of Hong KongUnknownComparative Effectiveness ResearchChina
-
University of North Carolina, Chapel HillCompleted
-
University of Colorado, DenverNational Library of Medicine (NLM)CompletedImmunization | Health Services Research | Comparative EffectivenessUnited States
Clinical Trials on Metformin 1000 mg granules
-
SandozCompleted
-
LG ChemUnknown
-
LG ChemCompleted
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2United States, Taiwan, Argentina, Canada, Philippines, Korea, Republic of, Mexico, Brazil, Pakistan
-
AstraZenecaParexelCompletedType 2 Diabetes MellitusUnited States
-
Dong-A ST Co., Ltd.CompletedType 2 Diabetes MellitusKorea, Republic of
-
SanofiCompleted
-
LG ChemUnknown
-
AstraZenecaCompleted
-
Ranbaxy Laboratories LimitedCompletedHealthyUnited States