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The purpose of this study was to assess bioequivalence (BE) of newly developed Glucophage® XR (GXR) reduced mass (RM) tablet (metformin hydrochloride 500 milligrams (mg) test tablet) and marketed Glucophage ® XR tablet (metformin hydrochloride 500 mg reference tablet) following single oral dose administration under fasted and fed conditions by comparing pharmacokinetics, safety and tolerability between test and reference in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Reference GXR (Fasting), Then Test GXR RM (Fasting) | Experimental | Participants received a single oral dose of 500 milligram (mg) of reference GXR (Glucophage® Extended Release) tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg test GXR RM (Reduced Mass) tablet on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
|
| First Test GXR RM (Fasting), Then Reference GXR (Fasting) | Experimental | Participants received a single oral dose of 500 milligrams (mg) of test GXR RM tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of reference GXR tablet on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
|
| First Reference GXR (Fed), Then Test GXR RM (Fed) | Experimental | Participants received a single oral dose of 500 milligrams (mg) of reference GXR tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of test GXR RM tablet on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
|
| First Test GXR RM (Fed), Then Reference GXR (Fed) | Experimental | Participants received a single oral dose of 500 milligrams (mg) of test GXR RM tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of reference GXR tablet on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucophage® XR RM Test | Drug | Participants received a single oral dose of 500 mg of test Glucophage® XR RM tablet under fasting or fed conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Metformin | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) of Metformin | Cmax was obtained directly from the concentration versus time curve. | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both Serious TEAEs and non-serious TEAEs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Chungnam National University Hospital | Daejeon | 35015 | South Korea |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contact | View source |
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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 https://bit.ly/IPD21
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A total of 56 participants were screened for the study in Part 1 (Fasted state) out of which 48 were randomized. For Part 2 (Fed state), a total of 49 participants were screened out of which 33 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | First Reference GXR (Fasting), Then Test GXR RM Tablet (Fasting) | Participants received a single oral dose of 500 milligram (mg) of reference GXR (Glucophage® Extended Release) tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg test GXR RM (Reduced Mass) tablet on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
| FG001 | First Test GXR RM (Fasting), Then Reference GXR (Fasting) | Participants received a single oral dose of 500 milligrams (mg) of test GXR RM tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of reference GXR tablet on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
| FG002 | First Reference GXR (Fed), Then Test GXR RM (Fed) | Participants received a single oral dose of 500 milligrams (mg) of reference GXR tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of test GXR RM tablet on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
| FG003 | First Test GXR RM (Fed), Then Reference GXR (Fed) | Participants received a single oral dose of 500 milligrams (mg) of test GXR RM tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of reference GXR tablet on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Day 1) |
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| ||||||||||||||||||
| Period 2(Day 8 up to 3 Months) |
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Demographic population included all those participants who participated in the bioequivalence study (that is all participants who were randomized)
| ID | Title | Description |
|---|---|---|
| BG000 | First Reference GXR (Fasting), Then Test GXR RM (Fasting) | Participants received a single oral dose of 500 mg of reference GXR tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg test GXR RM tablet on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Metformin | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | Pharmacokinetic Analysis Set included those participants who completed investigational medicinal product (IMP) administration and completed all pharmacokinetic blood collection. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliter (hr*ng/ml) | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
|
From informed consent (Day-28 to Day-2) up to 3 weeks, a maximum of 49 days.
The Safety Analysis Set included all participants who administered at least one dose of study interventions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference GXR (Fasting) | Participants received a single oral dose of 500 mg of reference GXR tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Human chorionic gonadotropin increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49 6151 72 5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2021 | Feb 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2022 | Feb 28, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
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| Glucophage® XR Reference | Drug | Participants received a single oral dose of 500 mg of reference Glucophage® XR tablet under fasting or fed conditions. |
|
|
| From Day 1 up to 3 weeks |
| Number of Participants Taking Concomitant Medications | Concomitant medications included medications administered from the first administration of study interventions to the end of observation. | From Day 1 up to 3 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | The laboratory measurements included hematology, blood chemistry, urinalysis and Blood Sugar Test (BST). Number of participants with clinically significant changes from baseline in laboratory values were reported. Clinically Significance was decided by investigator. | From Day1 (baseline) up to 3 weeks |
| Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | The 12-lead ECG recordings were obtained after 5 minutes of rest in a semi-supine position. ECG recordings included rhythm, ventricular rate, PR interval, QRS duration, QT and QTc intervals. Number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported. Clinically significance was decided by investigator. | From Day 1 (baseline) up to 3 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Vital sign assessment included blood pressure, pulse rate, body temperature and respiration rate. Number of participants with clinically significant changes from baseline in vital signs were reported. Clinically significance was decided by investigator. | From Day 1 (baseline) up to 3 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings | Physical examination included assessments of the skin, lungs, cardiovascular system, abdomen (liver and spleen), and the symptoms reported by the participant. Number of participants with clinically significant changes from baseline in vital signs were reported. Clinically significance was decided by investigator. | From Day 1 (baseline) up to 3 weeks |
| Area Under Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Metformin | AUC0-inf was calculated by combining AUC0-t and AUC extra. AUC extra represents an extrapolated value obtained by Clast/ lambda z, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and lambda z is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
| Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-tlast) to Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Metformin | The ratio of AUClast to AUCinf were reported. | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
| Apparent Terminal Half-Life (t1/2) of Metformin | Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z. | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metformin | Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
| Adverse Event |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 |
| First Test GXR RM (Fasting), Then Reference GXR (Fasting) |
Participants received a single oral dose of 500 milligrams (mg) of test GXR RM tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of reference GXR tablet on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
| BG002 | First Reference GXR (Fed), Then Test GXR RM (Fed) | Participants received a single oral dose of 500 milligrams (mg) of reference GXR tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of test GXR RM tablet on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
| BG003 | First Test GXR RM (Fed), Then Reference GXR (Fed) | Participants received a single oral dose of 500 milligrams (mg) of test GXR RM tablet on Day 1 in treatment period 1 followed by single oral dose of 500 mg of reference GXR tablet on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
Participants received a single oral dose of 500 miligrams (mg) of reference GXR tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period.
| OG001 | Test GXR RM (Fasting) | Participants received a single oral dose of 500 mg of test GXR RM tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. |
| OG002 | Reference GXR (Fed) | Participants received a single oral dose of 500 mg of reference GXR tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
| OG003 | Test GXR RM (Fed) | Participants received a single oral dose of 500 mg of test GXR RM tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. |
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Metformin | Cmax was obtained directly from the concentration versus time curve. | Pharmacokinetic Analysis Set included those participants who completed investigational medicinal product (IMP) administration and completed all pharmacokinetic blood collection. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both Serious TEAEs and non-serious TEAEs. | The Safety Analysis Set included all participants who administered at least one dose of study interventions. | Posted | Count of Participants | Participants | From Day 1 up to 3 weeks |
|
|
|
| Secondary | Number of Participants Taking Concomitant Medications | Concomitant medications included medications administered from the first administration of study interventions to the end of observation. | The Safety Analysis Set included all participants who administered at least one dose of study interventions. | Posted | Count of Participants | Participants | From Day 1 up to 3 weeks |
|
|
|
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | The laboratory measurements included hematology, blood chemistry, urinalysis and Blood Sugar Test (BST). Number of participants with clinically significant changes from baseline in laboratory values were reported. Clinically Significance was decided by investigator. | The Safety Analysis Set included all participants who administered at least one dose of study interventions. | Posted | Count of Participants | Participants | From Day1 (baseline) up to 3 weeks |
|
|
|
| Secondary | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | The 12-lead ECG recordings were obtained after 5 minutes of rest in a semi-supine position. ECG recordings included rhythm, ventricular rate, PR interval, QRS duration, QT and QTc intervals. Number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported. Clinically significance was decided by investigator. | The Safety Analysis Set included all participants who administered at least one dose of study interventions. | Posted | Count of Participants | Participants | From Day 1 (baseline) up to 3 weeks |
|
|
|
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Vital sign assessment included blood pressure, pulse rate, body temperature and respiration rate. Number of participants with clinically significant changes from baseline in vital signs were reported. Clinically significance was decided by investigator. | The Safety Analysis Set included all participants who administered at least one dose of study interventions. | Posted | Count of Participants | Participants | From Day 1 (baseline) up to 3 weeks |
|
|
|
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings | Physical examination included assessments of the skin, lungs, cardiovascular system, abdomen (liver and spleen), and the symptoms reported by the participant. Number of participants with clinically significant changes from baseline in vital signs were reported. Clinically significance was decided by investigator. | The Safety Analysis Set included all participants who administered at least one dose of study interventions. | Posted | Count of Participants | Participants | From Day 1 (baseline) up to 3 weeks |
|
|
|
| Secondary | Area Under Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Metformin | AUC0-inf was calculated by combining AUC0-t and AUC extra. AUC extra represents an extrapolated value obtained by Clast/ lambda z, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and lambda z is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | Pharmacokinetic Analysis Set included those participants who completed investigational medicinal product (IMP) administration and completed all pharmacokinetic blood collection. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/ml | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
|
|
|
| Secondary | Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-tlast) to Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Metformin | The ratio of AUClast to AUCinf were reported. | Pharmacokinetic Analysis Set included those participants who completed investigational medicinal product (IMP) administration and completed all pharmacokinetic blood collection. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
|
|
|
| Secondary | Apparent Terminal Half-Life (t1/2) of Metformin | Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z. | Pharmacokinetic Analysis Set included those participants who completed investigational medicinal product (IMP) administration and completed all pharmacokinetic blood collection. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metformin | Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | Pharmacokinetic Analysis Set included those participants who completed investigational medicinal product (IMP) administration and completed all pharmacokinetic blood collection. | Posted | Median | Full Range | hours | Part 1 (fasted): Pre-dose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24 and 32 hours post dose. Part 2 (fed): Pre-dose 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 24 and 32 hours post dose |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 7 |
| 47 |
| EG001 | Test GXR RM (Fasting) | Participants received a single oral dose of 500 mg of test GXR RM tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. | 0 | 48 | 0 | 48 | 7 | 48 |
| EG002 | Reference GXR (Fed) | Participants received a single oral dose of 500 mg of reference GXR tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. | 0 | 32 | 0 | 32 | 3 | 32 |
| EG003 | Test GXR RM (Fed) | Participants received a single oral dose of 500 mg of test GXR RM tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. | 0 | 31 | 0 | 31 | 2 | 31 |
| White blood cells urine positive | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Blood lactic acid increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Electrocardiogram PR prolongation | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
|
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| Serious TEAEs |
|
| Biochemistry |
|
| Urinalysis |
|
| Blood Sugar Test (BST) |
|