HealthyPhase 1NCT05463094
GXR RM China BE Study (Darmstadt - Jiangsu)
A Phase 1 study testing Test Glucophage® XR and Reference Glucophage® XR in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM) manufactured in Merck Jiangsu China (test product) and that manufactured in Merck Darmstadt… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test Glucophage® XR and Reference Glucophage® XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2022to 3 Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation, including medical history, ECG recording and physical examination judged by investigator.
- Participants with a body weight within 50 to 90 kg (kilogram) and BMI (body mass index) within the range 19 to 26 kg/m2 (kilogram per meter square).
- Participants with all values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator.
- Other protocol defined inclusion criteria could apply.
Who cannot join
- Participants with any surgical or medical condition, including findings in the medical history or in the pretrial assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation in the study or that could interfere with the study objectives, conduct or evaluation.
- Participants with history or presence of relevant liver diseases or hepatic or renal dysfunction.
- Participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the Investigator's opinion.
- Participation in a clinical study within 90 days prior to first drug administration.
- Non-acceptance of study high-fat breakfast.
- Other protocol defined exclusion criteria could apply .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage® XR RM Tablets (Merck/China Jiangsu-Manufactured) and 500 mg Glucophage® XR RM Tablets (Merck/Germany Darmstadt-Manufactured) Under Fed and Fasted State in Healthy Participants
The purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM) manufactured in Merck Jiangsu China (test product) and that manufactured in Merck Darmstadt Germany (reference product) administered under fasted and fed conditions.
- Conditions
- Healthy
- Being tested
- Test Glucophage® XR, Reference Glucophage® XR
- Keywords
- Bioequivalence, Glucophage® XR RM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Glucophage® XRDrug
Also called Metformin hydrochloride
Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.
Reference Glucophage® XRDrug
Also called Metformin hydrochloride
Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| First Test GXR RM (Fasted), Then Reference GXR RM (Fasted) | Experimental | Participants will receive a single dose of Test Glucophage Extended Release Reduced Mass (GXR RM) tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. Receives: Drug: Test Glucophage® XR; Drug: Reference Glucophage® XR |
| First Reference GXR RM (Fasted), Then Test GXR RM (Fasted) | Experimental | Participants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. Receives: Drug: Test Glucophage® XR; Drug: Reference Glucophage® XR |
| First Test GXR RM (Fed), Then Reference GXR RM (Fed) | Experimental | Participants will receive a single dose of Test GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. Receives: Drug: Test Glucophage® XR; Drug: Reference Glucophage® XR |
| First Reference GXR RM (Fed), Then Test GXR RM (Fed) | Experimental | Participants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. Receives: Drug: Test Glucophage® XR; Drug: Reference Glucophage® XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Metformin
Measured: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Maximum Observed Plasma Concentration (Cmax) of Metformin
Measured: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Secondary outcomes (3)
Pharmacokinetic Plasma Concentrations of Metformin
Measured: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Number of Participants with Treatment-Emergent Adverse Events (AEs)
Measured: Baseline up to Day 10
Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements and Physical Examination
Measured: Baseline up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start25 Jul 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463094
- Sponsor's protocol ID
- MS200084_0030
- Status last verified
- Apr 2023
- First submitted
- 14 Jul 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage® XR RM Tablets (Merck/China Jiangsu-Manufactured) and 500 mg Glucophage® XR RM Tablets (Merck/Germany Darmstadt-Manufactured) Under Fed and Fasted State in Healthy Participants
- ClinicalTrials.gov ID
- NCT05463094
- Acronym / sponsor ID
- MS200084_0030
- Conditions
- Healthy
- Keywords
- Bioequivalence, Glucophage® XR RM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 18 Jul 2022 (actual)
- 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 purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM) manufactured in Merck Jiangsu China (test product) and that manufactured in Merck Darmstadt Germany (reference product) administered under fasted and fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First Test GXR RM (Fasted), Then Reference GXR RM (Fasted) | Experimental | Drug: Test Glucophage® XR, Drug: Reference Glucophage® XRParticipants will receive a single dose of Test Glucophage Extended Release Reduced Mass (GXR RM) tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. |
| First Reference GXR RM (Fasted), Then Test GXR RM (Fasted) | Experimental | Drug: Test Glucophage® XR, Drug: Reference Glucophage® XRParticipants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period. |
| First Test GXR RM (Fed), Then Reference GXR RM (Fed) | Experimental | Drug: Test Glucophage® XR, Drug: Reference Glucophage® XRParticipants will receive a single dose of Test GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. |
| First Reference GXR RM (Fed), Then Test GXR RM (Fed) | Experimental | Drug: Test Glucophage® XR, Drug: Reference Glucophage® XRParticipants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who are overtly healthy as determined by medical evaluation, including medical history, ECG recording and physical examination judged by investigator.
- Participants with a body weight within 50 to 90 kg (kilogram) and BMI (body mass index) within the range 19 to 26 kg/m2 (kilogram per meter square).
- Participants with all values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator.
- Other protocol defined inclusion criteria could apply.
Key exclusion criteria (6 listed)
- Participants with any surgical or medical condition, including findings in the medical history or in the pretrial assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation in the study or that could interfere with the study objectives, conduct or evaluation.
- Participants with history or presence of relevant liver diseases or hepatic or renal dysfunction.
- Participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the Investigator's opinion.
- Participation in a clinical study within 90 days prior to first drug administration.
- Non-acceptance of study high-fat breakfast.
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 |
|---|---|---|
| Test Glucophage® XRAlso: Metformin hydrochlorideParticipants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions. | Drug | First Reference GXR RM (Fasted), Then Test GXR RM (Fasted), First Reference GXR RM (Fed), Then Test GXR RM (Fed), First Test GXR RM (Fasted), Then Reference GXR RM (Fasted), First Test GXR RM (Fed), Then Reference GXR RM (Fed) |
| Reference Glucophage® XRAlso: Metformin hydrochlorideParticipants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions. | Drug | First Reference GXR RM (Fasted), Then Test GXR RM (Fasted), First Reference GXR RM (Fed), Then Test GXR RM (Fed), First Test GXR RM (Fasted), Then Reference GXR RM (Fasted), First Test GXR RM (Fed), Then Reference GXR RM (Fed) |
Primary outcome
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Metformin
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Maximum Observed Plasma Concentration (Cmax) of Metformin
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
3 secondary outcomes
Pharmacokinetic Plasma Concentrations of Metformin
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Number of Participants with Treatment-Emergent Adverse Events (AEs)
Time frame: Baseline up to Day 10
Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements and Physical Examination
Time frame: Baseline up to Day 10
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 14 Apr 2023.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21
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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.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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 Test Glucophage® XR and Reference Glucophage® XR in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.
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 6 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 14 Apr 2023. 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 Germany. 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?
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Metformin (time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8). 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 14 Apr 2023.