Type 2 DiabetesPhase 1NCT01089179
Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 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 at 1 site in India.
Trial summary
Objective: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference formulation, Bristol- Myers Squibb company, USA) in… 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
- The subjects who qualify for the study should meet the following inclusion criteria.
- Male subjects in the range of 18 - 45 years of age.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature)
- Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray.
- Willingness to follow the protocol requirement as evidenced by written, informed consent.
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- Agreeing to, not using any medication (prescription and over the counter), including vitamins and minerals for two weeks prior to study \& during the course of the study.
- No history or presence of significant alcoholism or drug abuse in the past one year.
- Non-smokers, ex smokers and light smokers will be included. " Light smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely stopped smoking for at least 3 months.
Who cannot join
- The subjects who qualify for the study should not meet the following exclusion criteria:
- Requiring medication for any ailment including enzyme-modifying drugs Use of any drugs known to induce or inhibit hepatic drug metabolism (e.g.s, inducers: barbiturates, carbazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: selective serotonin reuptake inhibitors (SSRIs), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic or psychiatric diseases.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
- History of malignancy or other serious diseases.
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- Refusal to abstain from food for ten (10) hours prior to study drug administration on first day of each study period and for four (4) additional hours each, post dose.
- Refusal to abstain from water for one hour pre dose and for two (2) hours, post dosing.
- Any contraindication to blood sampling.
- Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period. Habituation of tobacco necessitating uninterrupted tobacco consumption.
- Use of xanthine-containing beverages or food for 48 hours prior to each drug dose.
- Blood donation 90 days prior to the commencement of the study.
- Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.
- Known history of allergic reactions to Metformin or other related drugs.
- History of drug abuse in the past one year.
- Use of prescription medication or over the counter products (including natural food supplements,vitamins, garlic as a supplement) within 2 weeks prior to administration of study medication, except for topical products without systemic absorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Volunteers Under Fed Conditions
Objective: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed Conditions.
Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089179
- Sponsor's protocol ID
- PK-07- 017
- Status last verified
- Mar 2010
- First submitted
- 16 Mar 2010
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 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 500 mg Tablet (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01089179
- Acronym / sponsor ID
- PK-07- 017
- 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: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed Conditions.
Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed 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 (9 listed)
- The subjects who qualify for the study should meet the following inclusion criteria.
Key exclusion criteria (16 listed)
- The subjects who qualify for the study should not meet the following exclusion 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 7 May 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.
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 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 9 inclusion and 16 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 7 May 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 7 May 2010.