HealthyPhase 1NCT02183571
Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
A Phase 1 study testing Merck Glucophage® high dose, BMS Glucophage® high dose and Merck Glucophage® low dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Merck Glucophage® high dose, BMS Glucophage® high dose and Merck Glucophage® low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Apr 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females according to the following criteria: a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG) and clinical laboratory tests
- Age ≥ 18 and Age ≤ 55 years
- BMI ≥ 18.5 and ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation
Who cannot join
- Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 23Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
- Participation in another trial with an investigational drug within two months prior to first study drug administration
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to the start of study)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for Torsade de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- For female subjects:
- Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 1 month after study completion
- No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
- Lactation
About this study
Official title: Bioequivalence of Two Strengths (1000 mg and 500 mg) of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects in an Open, Randomised, Single-dose, Two-period Crossover, Phase I Trial
Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)
- Conditions
- Healthy
- Being tested
- Merck Glucophage® high dose, BMS Glucophage® high dose, Merck Glucophage® low dose, BMS Glucophage® low dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Merck Glucophage® high doseDrug
Part I: Treatment A
BMS Glucophage® high doseDrug
Part I: Treatment B
Merck Glucophage® low doseDrug
Part II: Treatment C
BMS Glucophage® low doseDrug
Part II: Treatment D
| Study group | Role | What they receive |
|---|---|---|
| Glucophage® high dose | Experimental | Part I: Treatment A + B Receives: Drug: Merck Glucophage® high dose; Drug: BMS Glucophage® high dose |
| Glucophage® low dose | Experimental | Part II: Treatment C+ D Receives: Drug: Merck Glucophage® low dose; Drug: BMS Glucophage® low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-infinity (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 48 h after drug administration
Cmax (maximum measured concentration of metformin in plasma)
Measured: up to 48 hours after drug administration
Secondary outcomes (14)
AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 48 h after drug administration
AUCt1-t2 (Area under the concentration time curve of metformin in plasma over the time interval t1 to t2)
Measured: up to 48 h after drug administration
tmax (time from dosing to the maximum concentration of metformin in plasma)
Measured: up to 48 h after drug administration
λz (terminal rate constant in plasma)
Measured: up to 48 h after drug administration
t1/2 (terminal half-life of metformin in plasma)
Measured: up to 48 h after drug administration
MRTpo (mean residence time of metformin in the body after po administration)
Measured: up to 48 h after drug administration
CL/F (apparent clearance of metformin in the plasma after extravascular administration)
Measured: up to 48 h after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 48 h after drug administration
Number of patients with clinically relevant differences in physical examination
Measured: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with clinically relevant differences in vital signs (BP (Blood pressure), PR (Pulse rate))
Measured: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with clinically relevant differences in 12-lead ECG (electrocardiogram)
Measured: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with clinically relevant differences in clinical laboratory tests
Measured: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with adverse events
Measured: within 2- 10 after last study drug administration
Assessment of tolerability by investigator on a 4 point scale
Measured: within 2- 10 after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startFeb 2009
- Primary completionApr 2009
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.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183571
- Sponsor's protocol ID
- 1218.57
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Two Strengths (1000 mg and 500 mg) of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects in an Open, Randomised, Single-dose, Two-period Crossover, Phase I Trial
- ClinicalTrials.gov ID
- NCT02183571
- Acronym / sponsor ID
- 1218.57
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- First posted
- 8 Jul 2014 (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.
Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucophage® high dose | Experimental | Drug: Merck Glucophage® high dose, Drug: BMS Glucophage® high dosePart I: Treatment A + B |
| Glucophage® low dose | Experimental | Drug: Merck Glucophage® low dose, Drug: BMS Glucophage® low dosePart II: Treatment C+ D |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males and females according to the following criteria: a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG) and clinical laboratory tests
- Age ≥ 18 and Age ≤ 55 years
- BMI ≥ 18.5 and ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation
Key exclusion criteria (23 listed)
- Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| Merck Glucophage® high dosePart I: Treatment A | Drug | Glucophage® high dose |
| BMS Glucophage® high dosePart I: Treatment B | Drug | Glucophage® high dose |
| Merck Glucophage® low dosePart II: Treatment C | Drug | Glucophage® low dose |
| BMS Glucophage® low dosePart II: Treatment D | Drug | Glucophage® low dose |
Primary outcome
AUC0-infinity (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 48 h after drug administration
Cmax (maximum measured concentration of metformin in plasma)
Time frame: up to 48 hours after drug administration
14 secondary outcomes
AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 48 h after drug administration
AUCt1-t2 (Area under the concentration time curve of metformin in plasma over the time interval t1 to t2)
Time frame: up to 48 h after drug administration
tmax (time from dosing to the maximum concentration of metformin in plasma)
Time frame: up to 48 h after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 48 h after drug administration
t1/2 (terminal half-life of metformin in plasma)
Time frame: up to 48 h after drug administration
MRTpo (mean residence time of metformin in the body after po administration)
Time frame: up to 48 h after drug administration
CL/F (apparent clearance of metformin in the plasma after extravascular administration)
Time frame: up to 48 h after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 48 h after drug administration
Number of patients with clinically relevant differences in physical examination
Time frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with clinically relevant differences in vital signs (BP (Blood pressure), PR (Pulse rate))
Time frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with clinically relevant differences in 12-lead ECG (electrocardiogram)
Time frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with clinically relevant differences in clinical laboratory tests
Time frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with adverse events
Time frame: within 2- 10 after last study drug administration
Assessment of tolerability by investigator on a 4 point scale
Time frame: within 2- 10 after last study drug administration
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 8 Jul 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Merck Glucophage® high dose, BMS Glucophage® high dose and Merck Glucophage® low dose in people with Healthy, run by Boehringer Ingelheim.
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 4 inclusion and 23 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 8 Jul 2014. 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.
What does the primary outcome measure?
AUC0-infinity (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity) (time frame: up to 48 h after drug administration). The study lists 2 primary outcomes in all. 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 8 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.