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The study will assess the bioequivalence between single doses of glucophage immediate release (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Test GIR (Fasting), Then Reference GIR (Fasting) | Experimental | Participants received a single oral dose of 500 milligram (mg) of test Glucophage Immediate Release (GIR) tablet Sino-American Shanghai Squibb (SASS)/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (Merck Santé in Semoy (MSS)/France) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period. |
|
| First Reference GIR (Fasting), Then Test GIR (Fasting) | Experimental | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period. |
|
| First Test GIR (Fed), Then Reference GIR (Fed) | Experimental | Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (MSS/France) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
|
| First Reference GIR (Fed), Then Test GIR (Fed) | Experimental | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test GIR | Drug | Participants received 500 milligrams (mg) test GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Metformin (GIR Tablet Active Ingredient) | 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. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
| Maximum Observed Plasma Concentration (Cmax) of Metformin (GIR Tablet Active Ingredient) | Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration of Metformin (GIR Tablet Active Ingredient) | Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
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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 |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Beijing | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36264446 | Derived | Hu C, Gao D, Li D, Zhou D, Zhang L. Chinese- and French-Manufactured Immediate-Release Glucophage(R) Bioequivalence: A Randomized, Open-Label, Crossover Study. Drugs R D. 2022 Dec;22(4):301-309. doi: 10.1007/s40268-022-00405-3. Epub 2022 Oct 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | First Test GIR (Fasting), Then Reference GIR (Fasting) | Participants received a single oral dose of 500 milligram (mg) of test Glucophage Immediate Release (GIR) tablet Sino-American Shanghai Squibb (SASS)/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (Merck Santé in Semoy (MSS)/France) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period. |
| FG001 | First Reference GIR (Fasting), Then Test GIR (Fasting) | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period. |
| FG002 | First Test GIR (Fed), Then Reference GIR (Fed) | Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (MSS/France) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
| FG003 | First Reference GIR (Fed), Then Test GIR (Fed) | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Day 1-Day 3) |
| |||||||||||||
| Treatment Period 2 (Day 8- Day 10) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | First Test GIR (Fasting), Then Reference GIR (Fasting) | Participants received a single oral dose of 500 milligram (mg) of test Glucophage Immediate Release (GIR) tablet Sino-American Shanghai Squibb (SASS)/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (Merck Santé in Semoy (MSS)/France) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment 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 the Last Sampling Time (AUC 0-t) of Metformin (GIR Tablet Active Ingredient) | 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. | The Pharmacokinetic (PK) Analysis Set included all participants who completed the study with adequate study drug compliance, without any relevant protocol violations with respect to factors likely to affect comparability of PK results, and with sufficient evaluable data to determine primary endpoints (AUC0-t and Cmax ) for both treatments. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram hour per milliliter (ng*h/mL) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
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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 | Treatment A Test GIR (Fasting) | Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | 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 | Nov 20, 2017 | Jan 28, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2018 | Jan 28, 2019 | SAP_001.pdf |
| 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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|
|
| Reference GIR | Drug | Participants received 500 mg reference GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
|
|
| Apparent Terminal Half-Life (t1/2) of Metformin (GIR Tablet Active Ingredient) | 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 λz. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Metformin (GIR Tablet Active Ingredient) | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, 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 λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
| Area Under the Plasma Concentration-Time Curve From Time Tlast Extrapolated to Infinity (AUCextra) of Metformin (GIR Tablet Active Ingredient) | AUCextra% was defined as area under the curve from time tlast extrapolated to infinity as percentage of AUC 0-infinity. Here, tlast is the last sampling time at which the concentration is at or above the lower limit of quantification. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
| Elimination Rate Constant (λz) of Metformin (GIR Tablet Active Ingredient) | λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
| Total Body Clearance (CL/f) of Metformin (GIR Tablet Active Ingredient) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
| Apparent Volume of Distribution at After Extravascular Administration (Vz/f) of Metformin (GIR Tablet Active Ingredient) | Vz/f is defined as the distribution of a study drug between plasma and the rest of the body after oral dosing. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
| Apparent Volume of Distribution at Steady-State After Extravascular Administration (Vss/f) of Metformin | Vss/F was derived from concentration versus time data for all participants. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
| 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. | Baseline up to Day 15 |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters, Physical Examination Findings and 12-lead Electrocardiogram (ECG) Findings | The laboratory measurements included hematology, blood chemistry and urinalysis. Vital sign assessment included blood pressure, pulse rate and body temperature. ECG parameters included heart rate, PR, QRS,QT, RR, QTcB and QTcF Here, we are reporting number of participants with clinically significant abnormalities in Vital signs, laboratory parameters, physical findings and ECG findings. | Baseline up to Day 15 |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | First Reference GIR (Fasting), Then Test GIR (Fasting) | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period. |
| BG002 | First Test GIR (Fed), Then Reference GIR (Fed) | Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (MSS/France) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
| BG003 | First Reference GIR (Fed), Then Test GIR (Fed) | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Treatment A: Test GIR (Fasting) |
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions. |
| OG001 | Treatment B Reference GIR (Fasting) | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions. |
| OG002 | Treatment A: Test GIR (Fed) | Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions. |
| OG003 | Treatment B: Reference GIR (Fed) | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions. |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Metformin (GIR Tablet Active Ingredient) | Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve. | The Pharmacokinetic analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration of Metformin (GIR Tablet Active Ingredient) | Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | The Pharmacokinetic analysis set. | Posted | Median | Full Range | hours | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
|
|
|
| Secondary | Apparent Terminal Half-Life (t1/2) of Metformin (GIR Tablet Active Ingredient) | 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 λz. | The Pharmacokinetic analysis set. Here "Number of particpants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Metformin (GIR Tablet Active Ingredient) | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, 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 λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | The Pharmacokinetic analysis set. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Tlast Extrapolated to Infinity (AUCextra) of Metformin (GIR Tablet Active Ingredient) | AUCextra% was defined as area under the curve from time tlast extrapolated to infinity as percentage of AUC 0-infinity. Here, tlast is the last sampling time at which the concentration is at or above the lower limit of quantification. | As AUCextra was >20% of AUC0-inf, parameters derived from λz including AUCextra% were regarded as unreliable estimate of the extent of exposure and not calculated. | Posted | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
|
| Secondary | Elimination Rate Constant (λz) of Metformin (GIR Tablet Active Ingredient) | λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. | As AUCextra was >20% of AUC0-inf, parameters derived from λz were regarded as unreliable estimate of the extent of exposure and not calculated. | Posted | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
|
| Secondary | Total Body Clearance (CL/f) of Metformin (GIR Tablet Active Ingredient) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | The Pharmacokinetic analysis set. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
|
|
| Secondary | Apparent Volume of Distribution at After Extravascular Administration (Vz/f) of Metformin (GIR Tablet Active Ingredient) | Vz/f is defined as the distribution of a study drug between plasma and the rest of the body after oral dosing. | The Pharmacokinetic analysis set. . Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
|
|
| Secondary | Apparent Volume of Distribution at Steady-State After Extravascular Administration (Vss/f) of Metformin | Vss/F was derived from concentration versus time data for all participants. | As AUCextra was >20% of AUC0-inf, Vss/f derived from λz was regarded as unreliable estimate of the extent of exposure and not calculated. | Posted | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 |
|
|
| 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 received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Day 15 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters, Physical Examination Findings and 12-lead Electrocardiogram (ECG) Findings | The laboratory measurements included hematology, blood chemistry and urinalysis. Vital sign assessment included blood pressure, pulse rate and body temperature. ECG parameters included heart rate, PR, QRS,QT, RR, QTcB and QTcF Here, we are reporting number of participants with clinically significant abnormalities in Vital signs, laboratory parameters, physical findings and ECG findings. | The Safety Analysis Set included all participants who received at least 1 dose of study drug. Here "number of particpants were analyzed who were evaluable for this outcome measure". | Posted | Count of Participants | Participants | Baseline up to Day 15 |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 2 |
| 26 |
| EG001 | Treatment B Reference GIR (Fasting) | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions. | 0 | 26 | 0 | 26 | 2 | 26 |
| EG002 | Treatment A: Test GIR (Fed) | Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions. | 0 | 18 | 0 | 18 | 2 | 18 |
| EG003 | Treatment B: Reference GIR (Fed) | Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions. | 0 | 18 | 0 | 18 | 3 | 18 |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA version 20.1 | Systematic Assessment |
|
Not provided
Not provided
Statistical Comparison of Treatment A Versus Treatment B in Fed state
| Ratio of Geometric LS Mean Percentage |
| 101.50 |
| 90 |
| 93.72 |
| 109.92 |
| Equivalence |
Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00% |
Statistical Comparison of Treatment A Versus Treatment B in Fed state |
| Median Difference |
| 0.25 |
| 90 |
| -0.25 |
| 0.50 |
| Equivalence |
Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00% |
Statistical Comparison of Treatment A Versus Treatment B in Fed state
| Ratio of Geometric LS Mean Percentage |
| 98.17 |
| 2-Sided |
| 90 |
| 91.61 |
| 105.21 |
| Equivalence |
Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00% |
| Serious TEAE |
|
| Laboratory Parameters |
|
| Physical Examination |
|
| 12-Lead Electrocardiogram (ECG) |
|