HealthyNCT00778466
Bioequivalence Study of Metformin Hydrochloride 1000mg Tablets Under Fed Conditions
A study testing metformin hydrochloride 1000 mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial summary
The objective of this study was to evaluate the relative bioavailability of the test formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb Company) under fed conditions in healthy, male and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- metformin hydrochloride 1000 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Apr 2006
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females, 18 to 60 years of age (inclusive).
- A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations.
- Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study.
Who cannot join
- If female, pregnant, lactating or likely to become pregnant during the study.
- History or allergy or sensitivity to metformin, other hyperglycemic agents, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
- Presence of gastrointestinal disease or history of malabsorption within the last year.
- History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
- Presence of a medical condition requiring regular treatment with prescription drugs.
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- Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
- Receipt of any drug as part of a research study within 30 days prior to dosing.
- Drug or alcohol addiction requiring treatment in the past 12 months.
- Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
- Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
- Positive test results for drug of abuse at screening.
- Positive serum pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
NovumPharmaceutical Research Services
Las Vegas, Nevada, 89121
About this study
Official title: A Study to Compare the Relative Bioavailability of Ranbaxy and Bristol Myers Squibb Formulations of Metformin 1000 mg Tablets in Healthy Adult Volunteers Under Fed Conditions
The objective of this study was to evaluate the relative bioavailability of the test formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb Company) under fed conditions in healthy, male and female adult subjects.
Read the detailed description
This randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1000 mg metformin hydrochloride tablets under fed conditions. The study was conducted with 32 (30 completing) healthy adults in accordance with Protocol No. 10640303 (Revision 0). In each study period, a single dose (1 x 1000 mg tablet) was administered to all subjects following a standardized high fat breakfast preceded by an overnight fast of at least 10 hours. The test formulation was Ohm Laboratories, Inc's (A Group of Ranbaxy Pharmaceuticals Inc.) Metformin Hydrochloride 1000 mg Tablets and the reference formulation was GLUCOPHAGE® (metformin hydrochloride) 1000 mg Tablets (Bristol-Myers Squibb Company). The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.
Blood samples were collected pre-dose and at intervals over 24 hours after each dose. The plasma samples for all subjects completing both periods of the study were sent to Helen Fassoulas, Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul Industriel, Laval, Quebec, H7L4S3 Canada, Telephone: 450-663-6724, Fax: 450-975-8111 for determination of metformin concentrations.
Statistical analysis was performed by Braulio Suarez, M.D., Novum Pharmaceutical Research Services, Wilcrest Green Office Park, 3320 Walnut Bend Lane, Houston, Texas 77042-4712, USA, Telephone: 832-251-8100, Fax: 832-251-7133.
A total of 32 healthy adult subjects (30 completing).
- Conditions
- Healthy
- Being tested
- metformin hydrochloride 1000 mg tablets
- Keywords
- Bioequivalence metformin hydrochloride 1000 mg tablets fed conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin hydrochloride 1000 mg tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | metformin hydrochloride 1000 mg tablets of ranbaxy Receives: Drug: metformin hydrochloride 1000 mg tablets |
| 2 | Active comparator | GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets Receives: Drug: metformin hydrochloride 1000 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startFeb 2006
- Primary completionMar 2006
- Study completionApr 2006
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.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778466
- Sponsor's protocol ID
- 10640303
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Relative Bioavailability of Ranbaxy and Bristol Myers Squibb Formulations of Metformin 1000 mg Tablets in Healthy Adult Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00778466
- Acronym / sponsor ID
- 10640303
- Conditions
- Healthy
- Keywords
- Bioequivalence metformin hydrochloride 1000 mg tablets fed conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 23 Oct 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.
The objective of this study was to evaluate the relative bioavailability of the test formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb Company) under fed conditions in healthy, male and female adult subjects.
Detailed description
This randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1000 mg metformin hydrochloride tablets under fed conditions. The study was conducted with 32 (30 completing) healthy adults in accordance with Protocol No. 10640303 (Revision 0). In each study period, a single dose (1 x 1000 mg tablet) was administered to all subjects following a standardized high fat breakfast preceded by an overnight fast of at least 10 hours. The test formulation was Ohm Laboratories, Inc's (A Group of Ranbaxy Pharmaceuticals Inc.) Metformin Hydrochloride 1000 mg Tablets and the reference formulation was GLUCOPHAGE® (metformin hydrochloride) 1000 mg Tablets (Bristol-Myers Squibb Company). The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.
Blood samples were collected pre-dose and at intervals over 24 hours after each dose. The plasma samples for all subjects completing both periods of the study were sent to Helen Fassoulas, Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul Industriel, Laval, Quebec, H7L4S3 Canada, Telephone: 450-663-6724, Fax: 450-975-8111 for determination of metformin concentrations.
Statistical analysis was performed by Braulio Suarez, M.D., Novum Pharmaceutical Research Services, Wilcrest Green Office Park, 3320 Walnut Bend Lane, Houston, Texas 77042-4712, USA, Telephone: 832-251-8100, Fax: 832-251-7133.
A total of 32 healthy adult subjects (30 completing).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: metformin hydrochloride 1000 mg tabletsmetformin hydrochloride 1000 mg tablets of ranbaxy |
| 2 | Active comparator | Drug: metformin hydrochloride 1000 mg tabletsGLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females, 18 to 60 years of age (inclusive).
- A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations.
- Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study.
Key exclusion criteria (13 listed)
- If female, pregnant, lactating or likely to become pregnant during the study.
- History or allergy or sensitivity to metformin, other hyperglycemic agents, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
- Presence of gastrointestinal disease or history of malabsorption within the last year.
- History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
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 1000 mg tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 23 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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 study testing metformin hydrochloride 1000 mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
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 13 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 23 Oct 2008. 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 United States. 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 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. 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 23 Oct 2008.