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This study investigated the bioequivalence and drug-drug interaction of Metformin/Gliclazide fixed combination tablet compared to co-administration of individual tablets of Metformin and Gliclazide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | Participants received single oral dose of metformin 1000 milligram (mg) and gliclazide 30 mg fixed combination tablet in treatment period 1 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg in treatment period 3 and then a single oral dose of gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
|
| Treatment Sequence 2 | Experimental | Participants received concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 1 followed by single oral dose of gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 3 and then single oral dose of metformin 1000 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
|
| Treatment Sequence 3 | Experimental | Participants received single oral dose of metformin 1000 mg in treatment period 1 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 2 followed by single oral dose of gliclazide 30 mg in treatment period 3 and then concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin/Gliclazide Fixed Combination | Drug | Participants received single oral dose of Metformin and Gliclazide fixed combination tablet in treatment period 1, 2, 3 or 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Metformin | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Gliclazide | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of Metformin | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of Gliclazide | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose | |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Metformin | AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Gliclazide | AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent Volume of Distribution (Vz/f) of Metformin | Vz/f was defined as apparent volume of distribution during terminal phase after non-intravenous administration. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Apparent Volume of Distribution (Vz/f) of Gliclazide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact the Merck KGaA Communication Center | Darmstadt | 64293 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1 | Participants received single oral dose of metformin 1000 milligram (mg) and gliclazide 30 mg fixed combination tablet in treatment period 1 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg in treatment period 3 and then a single oral dose of gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| FG001 | Treatment Sequence 2 | Participants received concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 1 followed by single oral dose of gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 3 and then single oral dose of metformin 1000 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| FG002 | Treatment Sequence 3 | Participants received single oral dose of metformin 1000 mg in treatment period 1 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 2 followed by single oral dose of gliclazide 30 mg in treatment period 3 and then concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| FG003 | Treatment Sequence 4 | Participants received single oral dose of gliclazide 30 mg in treatment period 1 followed by single oral dose of metformin 1000 mg in treatment period 2 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 3 and then single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
| |||||||||||||
| Treatment Period 2 |
| |||||||||||||
| Treatment Period 3 |
| |||||||||||||
| Treatment Period 4 |
|
All participants who were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1 | Participants received single oral dose of metformin 1000 milligram (mg) and gliclazide 30 mg fixed combination tablet in treatment period 1 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg in treatment period 3 and then a single oral dose of gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Last Measurable Concentration (AUC0-t) of Metformin | The Pharmacokinetic (PK) analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng*h/ml) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
Baseline up to Day 72
The safety population included all participants who received at least 1 dose of the trial treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin-Gliclazide Combination | Participants received single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet either in treatment period 1, 2, 3 or 4. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated triglycerides | Investigations | MedDRA, Version 22.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2018 | Apr 26, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 18, 2017 | Apr 26, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D005907 | Gliclazide |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000096926 |
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| Treatment Sequence 4 | Experimental | Participants received single oral dose of gliclazide 30 mg in treatment period 1 followed by single oral dose of metformin 1000 mg in treatment period 2 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 3 and then single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
|
| Metformin | Drug | Participants received single oral dose of Metformin tablet in treatment period 1, 2, 3 or 4. |
|
| Gliclazide | Drug | Participants received single oral dose of Gliclazide tablet in treatment period 1, 2, 3 or 4. |
|
Vz/f was defined as apparent volume of distribution during terminal phase after non-intravenous administration. |
| Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Elimination Half Life (t1/2) of Metformin | Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Elimination Half Life (t1/2) of Gliclazide | Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Apparent Total Body Clearance (CL/f) of Metformin | CL/f was defined as apparent total clearance of the drug from plasma after oral administration. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Apparent Total Body Clearance (CL/f) of Gliclazide | CL/f was defined as apparent total clearance of the drug from plasma after oral administration. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Median Residence Time (MRT) for Metformin | MRT is the average time that the molecules introduced into the body stays in the body. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Median Residence Time (MRT) for Gliclazide | MRT is the average time that the molecules introduced into the body stays in the body. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally 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. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs included both Serious TEAEs and non-serious TEAEs. | Baseline up to Day 72 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Treatment Sequence 2 | Participants received concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 1 followed by single oral dose of gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 3 and then single oral dose of metformin 1000 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| BG002 | Treatment Sequence 3 | Participants received single oral dose of metformin 1000 mg in treatment period 1 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 2 followed by single oral dose of gliclazide 30 mg in treatment period 3 and then concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| BG003 | Treatment Sequence 4 | Participants received single oral dose of gliclazide 30 mg in treatment period 1 followed by single oral dose of metformin 1000 mg in treatment period 2 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 3 and then single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 4. Each treatment period was separated by a 14-day wash-out period. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
Participants received single oral dose of metformin 1000 mg and gliclazide 30 mg separately either in treatment period 1, 2, 3 or 4. |
| OG002 | Metformin | Participants received single oral dose of metformin 1000 mg either in treatment period 1, 2, 3 or 4. |
|
|
|
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Gliclazide | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | ng.h/ml | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Metformin | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/ml) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Gliclazide | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | ng/ml | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Metformin | AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | ng*h/ml | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Gliclazide | AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | ng*h/ml | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/f) of Metformin | Vz/f was defined as apparent volume of distribution during terminal phase after non-intravenous administration. | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | Milliliter | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/f) of Gliclazide | Vz/f was defined as apparent volume of distribution during terminal phase after non-intravenous administration. | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | Milliliter | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
| Secondary | Elimination Half Life (t1/2) of Metformin | Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | Hours | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
| Secondary | Elimination Half Life (t1/2) of Gliclazide | Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | Hours | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
| Secondary | Apparent Total Body Clearance (CL/f) of Metformin | CL/f was defined as apparent total clearance of the drug from plasma after oral administration. | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | Milliliter per Hour (mL/ h) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
| Secondary | Apparent Total Body Clearance (CL/f) of Gliclazide | CL/f was defined as apparent total clearance of the drug from plasma after oral administration. | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | mL/h | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
| Secondary | Median Residence Time (MRT) for Metformin | MRT is the average time that the molecules introduced into the body stays in the body. | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | Hours | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
| Secondary | Median Residence Time (MRT) for Gliclazide | MRT is the average time that the molecules introduced into the body stays in the body. | The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results. | Posted | Mean | Standard Deviation | Hours | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally 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. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs included both Serious TEAEs and non-serious TEAEs. | The safety population included all participants who received at least 1 dose of the trial treatment. | Posted | Count of Participants | Participants | Baseline up to Day 72 |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 9 |
| 35 |
| EG001 | Metformin and Gliclazide Separately | Participants received single oral dose of metformin 1000 mg and gliclazide 30 mg separately either in treatment period 1, 2, 3 or 4. | 0 | 35 | 0 | 35 | 6 | 35 |
| EG002 | Metformin | Participants received single oral dose of metformin 1000 mg either in treatment period 1, 2, 3 or 4. | 0 | 35 | 0 | 35 | 7 | 35 |
| EG003 | Gliclazide | Participants received single oral dose of gliclazide 30mg either in treatment period 1, 2, 3 or 4. | 0 | 35 | 0 | 35 | 8 | 35 |
| High cholesterol | Investigations | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Elevated alanine aminostrasferase | Investigations | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Elevated aspartate aminotrasferase | Investigations | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Vasovagal reaction | Nervous system disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Infectious gastroenteritis | Gastrointestinal disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Wound in the left submaxillary region | Injury, poisoning and procedural complications | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Urinary infection | Infections and infestations | MedDRA, Version 22.0 | Non-systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA, Version 22.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| Geometric Least Squares Mean Ratio |
| 105.7255 |
| 2-Sided |
| 90 |
| 101.1665 |
| 110.4900 |
| Equivalence |
Bioequivalence boundaries of 80.000% to 125.00% were used. |
| Geometric Least Squares Mean Ratio | 96.7533 | 2-Sided | 90 | 92.5812 | 101.1135 | Equivalence | Bioequivalence boundaries of 80.000% to 125.00% were used. |
| Geometric Least Squares Mean Ratio |
| 108.0819 |
| 2-Sided |
| 90 |
| 102.2370 |
| 114.2609 |
| Equivalence |
Bioequivalence boundaries of 80.000% to 125.00% were used. |
| Geometric Least Squares Mean Ratio | 79.4367 | 2-Sided | 90 | 71.9633 | 87.6861 | Equivalence | Bioequivalence boundaries of 80.000% to 125.00% were used. |
| Geometric Least Squares Mean Ratio |
| 93.6828 |
| 2-Sided |
| 90 |
| 88.6166 |
| 99.0386 |
| Equivalence |
Bioequivalence boundaries of 80.000% to 125.00% were used. |
| Geometric Least Squares Mean Ratio | 115.3700 | 2-Sided | 90 | 109.1310 | 121.9658 | Equivalence | Bioequivalence boundaries of 80.000% to 125.00% were used. |
| Geometric Least Squares Mean Ratio |
| 101.8499 |
| 2-Sided |
| 90 |
| 97.8819 |
| 106.9028 |
| Equivalence |
Bioequivalence boundaries of 80.000% to 125.00% were used. |
| Geometric Least Squares Mean Ratio | 81.0112 | 2-Sided | 90 | 74.8823 | 87.6417 | Equivalence | Bioequivalence boundaries of 80.000% to 125.00% were used. |
| Geometric Least Squares Mean Ratio |
| 105.9150 |
| 2-Sided |
| 90 |
| 101.4900 |
| 110.5330 |
| Equivalence |
Bioequivalence boundaries of 80.000% to 125.00% were used. |
| Geometric Least Squares Mean Ratio | 96.1619 | 2-Sided | 90 | 92.1443 | 100.3546 | Equivalence | Bioequivalence boundaries of 80.000% to 125.00% were used. |
| SAEs |
|