FastingPhase 1NCT01831674
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fed Condition
A Phase 1 study testing Metformin Hydrochloride Extended-Release Tablets USP 750 and GLUCOPHAGE®XR tablet 750 mg in people with Fasting, run by IPCA Laboratories Ltd. at 1 site in India.
Trial summary
The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fed condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Metformin Hydrochloride Extended-Release Tablets USP 750 and GLUCOPHAGE®XR tablet 750 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2012to Feb 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged between 18 and 45 years (including both).
- Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) (including both) with minimum of 50 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view).
- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
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- Subjects having negative alcohol breathe test.
- Subjects willing to adhere to protocol requirements and to provide written informed consent.
- Subjects having negative Beta-hCG Pregnancy test (only for female subjects).
- For Female Subjects:
- 1) Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or 2) Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above 3) Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Who cannot join
- Hypersensitivity to Metformin or to any excipients or related class of drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting
- History or Presence of significant alcoholism or drug abuse.
- History or presence of significant asthma, urticaria or other allergic reactions.
- History or presence of significant gastric and/or duodenal ulceration.
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- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of cancer.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Subjects who have been on an abnormal diet (for whatever reason) during four weeks preceding the study.
- Difficulty with donating blood.
- Difficulty in swallowing solids like tablets or capsules.
- Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
- Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to dosing.
- Major illness during 3 months before screening.
- Participation in a drug research study within past 3 months.
- Donation of blood from past 3 months before screening.
- Female subjects who are currently breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Two-treatment, Two -Period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl Extended-release Tablets) 750 mg of Bristol-Myers Squibb Company, USA in Normal, Healthy, Adult, Human Subjects Under Fed Condition
The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fed condition.
Read the detailed description
Objective of the study is to compare and evaluate the single-dose oral bioavailability of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl extended-release tablets) 750 mg of Bristol-Myers Squibb Company, USA in normal, healthy, adult, human subjects under fed condition.
Total duration of the study was of 17 days from the day of admission of first period till the end of second period.
Upon entering into the study, subjects were housed in clinical facility of Veeda Clinical Research Pvt. Ltd. to ensure 10 hours overnight fasting before dosing and continued to be housed in the facility till 36.00 hours post-dose blood sample collection in each of the two periods.
A gap of 14 days was kept as wash out between each consecutive dosing period.
- Conditions
- Fasting
- Being tested
- Metformin Hydrochloride Extended-Release Tablets USP 750, GLUCOPHAGE®XR tablet 750 mg
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride Extended-Release Tablets USP 750Drug
Also called Test product
Metformin Hydrochloride Extended-Release Tablets 750 mg once a day
GLUCOPHAGE®XR tablet 750 mgDrug
Also called Reference product
GLUCOPHAGE®XR 750 mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Metformin Hydrochloride Extended-Release Tablets USP 750 | Experimental | Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India Receives: Drug: Metformin Hydrochloride Extended-Release Tablets USP 750; Drug: GLUCOPHAGE®XR tablet 750 mg |
| GLUCOPHAGE®XR | Active comparator | GLUCOPHAGE®XR tablet 750 mg of Bristol-Myers Squibb Company, USA Receives: Drug: Metformin Hydrochloride Extended-Release Tablets USP 750; Drug: GLUCOPHAGE®XR tablet 750 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence is based on Cmax and AUC parameters.
Pre-dose \& at 1.00, 2.00, 3.00, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 30.00 and 36.00 hours post-dose.
Measured: 1 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- IPCA Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Hardik Dave, M.B.B.S, Principal investigator, Veeda Clinical Research Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831674
- Sponsor's protocol ID
- 10-VIN-184
- Status last verified
- Apr 2013
- First submitted
- 6 Apr 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two-treatment, Two -Period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl Extended-release Tablets) 750 mg of Bristol-Myers Squibb Company, USA in Normal, Healthy, Adult, Human Subjects Under Fed Condition
- ClinicalTrials.gov ID
- NCT01831674
- Acronym / sponsor ID
- 10-VIN-184
- Conditions
- Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- IPCA Laboratories Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Apr 2013 (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 study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fed condition.
Detailed description
Objective of the study is to compare and evaluate the single-dose oral bioavailability of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl extended-release tablets) 750 mg of Bristol-Myers Squibb Company, USA in normal, healthy, adult, human subjects under fed condition.
Total duration of the study was of 17 days from the day of admission of first period till the end of second period.
Upon entering into the study, subjects were housed in clinical facility of Veeda Clinical Research Pvt. Ltd. to ensure 10 hours overnight fasting before dosing and continued to be housed in the facility till 36.00 hours post-dose blood sample collection in each of the two periods.
A gap of 14 days was kept as wash out between each consecutive dosing period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Hydrochloride Extended-Release Tablets USP 750 | Experimental | Drug: Metformin Hydrochloride Extended-Release Tablets USP 750, Drug: GLUCOPHAGE®XR tablet 750 mgMetformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India |
| GLUCOPHAGE®XR | Active comparator | Drug: Metformin Hydrochloride Extended-Release Tablets USP 750, Drug: GLUCOPHAGE®XR tablet 750 mgGLUCOPHAGE®XR tablet 750 mg of Bristol-Myers Squibb Company, USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subjects aged between 18 and 45 years (including both).
- Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) (including both) with minimum of 50 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view).
Key exclusion criteria (19 listed)
- Hypersensitivity to Metformin or to any excipients or related class of drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting
- History or Presence of significant alcoholism or drug abuse.
- History or presence of significant asthma, urticaria or other allergic reactions.
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 Hydrochloride Extended-Release Tablets USP 750Also: Test productMetformin Hydrochloride Extended-Release Tablets 750 mg once a day | Drug | GLUCOPHAGE®XR, Metformin Hydrochloride Extended-Release Tablets USP 750 |
| GLUCOPHAGE®XR tablet 750 mgAlso: Reference productGLUCOPHAGE®XR 750 mg once a day | Drug | GLUCOPHAGE®XR, Metformin Hydrochloride Extended-Release Tablets USP 750 |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters.
Time frame: 1 Months
Pre-dose \& at 1.00, 2.00, 3.00, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 30.00 and 36.00 hours post-dose.
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 15 Apr 2013.
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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.
Dr. Hardik Dave, M.B.B.S principal investigator
Veeda Clinical Research Pvt. 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 Hydrochloride Extended-Release Tablets USP 750 and GLUCOPHAGE®XR tablet 750 mg in people with Fasting, run by IPCA Laboratories Ltd. 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 11 inclusion and 19 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 15 Apr 2013. 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.
What does the primary outcome measure?
Bioequivalence is based on Cmax and AUC parameters. (time frame: 1 Months). 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 15 Apr 2013.