Type 2 DiabetesPhase 1NCT01089166
Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition
A Phase 1 study testing Metformin in people with Type 2 Diabetes, run by Torrent Pharmaceuticals Limited at 1 site in India.
Trial summary
Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIndia
- Study dates
- Start not givento not given
- 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 45 years
- Men only
- Adult
Who may be able to join
- Subjects must meet all of the following criteria in order to be included in the study:
- Sex: male.
- Age: 18 - 45 years.
- Subject with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- Healthy and willing to participate in the study.
- Subject willing to adhere to the protocol requirements and to provide written informed consent.
- Non-smokers or smoker who smokes less than 10 cigarettes a day.
Who cannot join
- The subjects will be excluded from the study based on the following criteria:
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG or Chest X-ray.
- Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- Pulse rate less than 50/minute or more than 100/minute.
- Oral temperature less than 95°F or more than 98.6°F.
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- Respiratory rate less than 12/minute or more than 20/minute
- Addiction to alcohol or history of any drug abuse within the past 2 years.
- Recent History of kidney or liver dysfunction.
- History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- Administration/ Intake of prescription or OTC medication for two weeks before the study.
- Patients suffering from any chronic illness such as arthritis, asthma etc.
- HIV, HCV, HBsAg positive Subjects.
- Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, Cocaine positive Subjects based on urine test.
- Subjects suffering from any psychiatric (acute or chronic) illness requiring medications.
- Administration of any investigational products in the period 0 to 3 months before entry to the study.
- Intake of barbiturates or any enzyme-inducing drug in last three months.
- History of significant blood loss due to any reason, including blood donation in the past 12 weeks. The total blood loss in last 3 months including for this study will not exceed 350ml.
- History of any bleeding disorder.
- Existence of any surgical or medical condition, which, in the judgement of the Chief investigator and/or clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of Subjects.
- Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Bioavailability of Extended Release Metformin HCl Tablet(Test Formulation, Torrent Pharmaceuticals Ltd.,India) Versus Glucophage XR® Tablets ( Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers Under Fasting Condition
Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting condition.
Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting condition.
- Conditions
- Type 2 Diabetes
- Being tested
- Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Torrent's Metformin tablets 500 mg | Experimental | Not described Receives: Drug: Metformin |
| Glucophage XR® of Bristol- Myers Squibb Company, USA) | Active comparator | Not described Receives: Drug: Metformin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jogesh mahajan, MBBS, Principal investigator, Torrent Pharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089166
- Sponsor's protocol ID
- PK-07- 016
- Status last verified
- Mar 2010
- First submitted
- 16 Mar 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Bioavailability of Extended Release Metformin HCl Tablet(Test Formulation, Torrent Pharmaceuticals Ltd.,India) Versus Glucophage XR® Tablets ( Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers Under Fasting Condition
- ClinicalTrials.gov ID
- NCT01089166
- Acronym / sponsor ID
- PK-07- 016
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- First posted
- 18 Mar 2010 (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.
Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting condition.
Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting condition.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Torrent's Metformin tablets 500 mg | Experimental | Drug: Metformin |
| Glucophage XR® of Bristol- Myers Squibb Company, USA) | Active comparator | Drug: Metformin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must meet all of the following criteria in order to be included in the study:
Key exclusion criteria (21 listed)
- The subjects will be excluded from the study based on the following criteria:
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 | Drug | Glucophage XR® of Bristol- Myers Squibb Company, USA), Torrent's Metformin tablets 500 mg |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Related InfoLink provided by the sponsor.
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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.
Jogesh mahajan, MBBS principal investigator
Torrent Pharma Ltd.
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 in people with Type 2 Diabetes, run by Torrent Pharmaceuticals Limited at 1 site in India.
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 7 inclusion and 21 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: finished, as of the sponsor's last update on 22 Jun 2010. 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 India. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 22 Jun 2010.