Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.

A Phase 1 study testing Metformin in people with Type 2 Diabetes, run by Torrent Pharmaceuticals Limited.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Objective: To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fed Conditions. 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: No sites listed yet
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

Volunteers must meet all of the following criteria in order to be included in the study:
Sex: male.
Age: 18 - 45 years.
Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
Healthy and willing to participate in the study.
Volunteer 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 volunteers 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.

Show all 20Show fewer

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 volunteers.
Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, Cocaine positive volunteers based on urine test.
Volunteers 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.
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 Volunteers.
Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.

About this study

Official title: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Volunteers Under Fed Conditions.

Objective:

To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fed Conditions.

Study Design:

An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study

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 groups in NCT01089205
Study group	Role	What they receive
Torrent's Metformin tablets 750 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

IDs, dates and publications

ClinicalTrials.gov ID: NCT01089205
Sponsor's protocol ID: PK-07-019
Status last verified: Mar 2010
First submitted: 16 Mar 2010
Last updated: 29 Jul 2010
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Volunteers Under Fed Conditions.
ClinicalTrials.gov ID: NCT01089205
Acronym / sponsor ID: PK-07-019
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:

Study Design:

An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study

Study design

Number of arms: 2

Arm	Type	Receives
Torrent's Metformin tablets 750 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)

Volunteers must meet all of the following criteria in order to be included in the study:

Key exclusion criteria (20 listed)

The volunteers 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 750 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 29 Jul 2010.
Related InfoLink provided by the sponsor.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

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.

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 20 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 29 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

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?

On the ClinicalTrials.gov record for NCT01089205.

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 29 Jul 2010.