HealthyNCT00648869
Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers
A study testing metformin tablet, metformin gum in people with Healthy, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3 period, 3 treatments, and randomized design. Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg \& Metformin tablet 500mg Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- metformin tablet, metformin gum
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Nov 2008
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men ranging in age from 18-40
- Good general health as determined by medical history, physical examination, ECG, Blood pressure, and clinical laboratory tests (hematology \& clinical chemistry) obtained within 14 days prior to the start of the study.
- BMI >18\&<30.
- Willing and able to abide by the dietary requirements of the study.
- Willing and able to give written informed consent in a manner approved by the Ethics Committee.
Who cannot join
- History of known or suspected clinically significant hypersensitivity to any drug.
- Any protocol-required laboratory test abnormality that is considered clinically significant.
- Mentally unstable or incompetent.
- Any illness during the week before.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Diabetes Unit, Hadassah Hebew University Hospital
Jerusalem, 91120
About this study
Official title: Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers
Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3 period, 3 treatments, and randomized design.
Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg \& Metformin tablet 500mg
- Conditions
- Healthy
- Being tested
- metformin tablet, metformin gum
- Keywords
- pharmaceutical preparations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin tablet, metformin gumDrug
500 mg, 250 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).
Measured: 45 days
Secondary outcomes (1)
To evaluate the effect on blood glucose levels as well as safety and tolerability of one time administration of the Metformin Gum and Metformin tablet.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008 (estimated)
- Study completionNov 2008 (estimated)
Why it stopped: Drug was not sent
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Itamar Raz, MD, Principal investigator, Hadassah Hebrew University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648869
- Sponsor's protocol ID
- generex-HMO-CTIL
- Status last verified
- Mar 2008
- First submitted
- 27 Mar 2008
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00648869
- Acronym / sponsor ID
- generex-HMO-CTIL
- Conditions
- Healthy
- Keywords
- pharmaceutical preparations
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug was not sent
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 1 Apr 2008 (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.
Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3 period, 3 treatments, and randomized design.
Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg \& Metformin tablet 500mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men ranging in age from 18-40
- Good general health as determined by medical history, physical examination, ECG, Blood pressure, and clinical laboratory tests (hematology \& clinical chemistry) obtained within 14 days prior to the start of the study.
- BMI >18\&<30.
- Willing and able to abide by the dietary requirements of the study.
- Willing and able to give written informed consent in a manner approved by the Ethics Committee.
Key exclusion criteria (4 listed)
- History of known or suspected clinically significant hypersensitivity to any drug.
- Any protocol-required laboratory test abnormality that is considered clinically significant.
- Mentally unstable or incompetent.
- Any illness during the week before.
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 tablet, metformin gum500 mg, 250 mg | Drug | – |
Primary outcome
To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).
Time frame: 45 days
1 secondary outcome
To evaluate the effect on blood glucose levels as well as safety and tolerability of one time administration of the Metformin Gum and Metformin tablet.
Time frame: 45 days
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 27 Oct 2009.
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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.
Itamar Raz, MD principal investigator
Hadassah Hebrew University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metformin tablet, metformin gum in people with Healthy, run by Hadassah Medical Organization at 1 site in Israel.
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 5 inclusion and 4 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 27 Oct 2009. 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 Israel. 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.
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?
To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet). (time frame: 45 days). 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 27 Oct 2009.