Comparative BioavailabilityPhase 1NCT02217670
Comparative Bioavailability Study of Metformin HCl 1000 mg Granules vs Glucophage 1000 mg Film-coated Tablet
A Phase 1 study testing Metformin 1000 mg granules and Metformin 1000 mg film-coated tablets in people with Comparative Bioavailability, run by Disphar International B.V. at 1 site in Jordan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparative Bioavailability
- What is being tested?
- Metformin 1000 mg granules and Metformin 1000 mg film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJordan
- Study dates
- Start not givento Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Comparative Bioavailability
- Being tested
- Metformin 1000 mg granules, Metformin 1000 mg film-coated tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 1000 mg granulesDrug
Metformin 1000 mg film-coated tabletsDrug
Also called Glucophage
| Study group | Role | What they receive |
|---|---|---|
| Metformin (test) | Experimental | single oral dose of Metformin 1000 mg granules Receives: Drug: Metformin 1000 mg granules |
| Metformin (reference) | Active comparator | Single dose of Glucophage 1000 mg film-coated tablet Receives: Drug: Metformin 1000 mg film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t)
Measured: 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
Measured: 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 outcomes (4)
tmax
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Primary completionJan 2016 (estimated)
Why it stopped: Commercial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparative BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Disphar International B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217670
- Sponsor's protocol ID
- METF-GT016
- Status last verified
- Jan 2016
- First submitted
- 14 Aug 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Bioavailability Study of Metformin HCl 1000 mg Granules vs Glucophage 1000 mg Film-coated Tablet
- ClinicalTrials.gov ID
- NCT02217670
- Acronym / sponsor ID
- METF-GT016
- Conditions
- Comparative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Commercial reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Disphar International B.V.Industry (pharma, biotech, devices)
- Primary completion
- Jan 2016 (estimated)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin (test) | Experimental | Drug: Metformin 1000 mg granulessingle oral dose of Metformin 1000 mg granules |
| Metformin (reference) | Active comparator | Drug: Metformin 1000 mg film-coated tabletsSingle dose of Glucophage 1000 mg film-coated tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin 1000 mg granules | Drug | Metformin (test) |
| Metformin 1000 mg film-coated tabletsAlso: Glucophage | Drug | Metformin (reference) |
Primary outcome
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.
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin 1000 mg granules and Metformin 1000 mg film-coated tablets in people with Comparative Bioavailability, run by Disphar International B.V. at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.