Diffuse, Mantle Cell Lymphoma, Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large Cell, Non-Hodgkin's Lymphoma
Conditions
Keywords
Non-Hodgkin's lymphoma, Lymphoma, Large B-Cell, Diffuse, Mantle cell lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
Brief summary
The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.
Detailed description
Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m\^2/day on day2 and 3 in combination with rituximab at 375 mg/m\^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.
Interventions
DRUGSyB L-0501
The administration of SyB L-0501 at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. SyB L-0501 60 mg/m\^2, 90 mg/m\^2 or 120 mg/m\^2/day on Day 2 and Day 3 will be followed by 18 days of observation.
DRUGRituximab
The administration of rituximab at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
Sponsors
SymBio Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells * Patients with measurable lesions * Patients with measurable lesions \>1.5 cm in major axes * Relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large B-cell lymphoma. * Patients who are expected to survive for at least 3 months * Patients aged from 20 to 75 years at the time informed consent is obtained * Performance Status (P.S.) of 0 to 1 at initial administration of the study drug * Patients with adequately maintained organ functions * Patients capable of personally giving voluntary informed consent in writing to participate in the study
Exclusion criteria
* Patients who have been without treatment for less than 3 weeks after prior treatment * Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator. * Patients who received adequate prior treatments and did not respond to any of them. * Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement. * Patients with serious, active infections * Patients with serious complications * Patients with complications or medical history of serious cardiac disease * Patients with serious gastrointestinal symptoms * Patients with malignant pleural effusion, cardiac effusion, or ascites retention * Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody * Patients with serious bleeding tendencies * Patients with a fever of 38.0°C or higher * Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema * Patients with active multiple primary cancer or patients with a history of other malignant cancer within the past 5 years, except for basal cell cancer of the skin, squamous cell cancer, or cervical cancer in situ * Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia * Patients who received SyB L-0501 in the past * Patients who received cytokine preparation such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 2 weeks before the examination at registration for this study * Patients who received other investigational products or unapproved medication within 3 months before registration in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma | up to 30 weeks | CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma | up to 30 weeks | The criteria for CR is as below Nodal Masses: 1. fluorodeoxy glucose (FDG)-avid or positron emission tomography (PET) positive prior to therapy; mass of any size permitted if PET negative 2. Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT) Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative |
| Progression Free Survival (PFS) | up to 30 weeks | PFS = day of the first PFS event - day of start of study treatment + 1 The definitions of PFS event are as below. 1. PD according to overall response on the basis of Revised Response Criteria for Malignant Lymphoma PD: Any new lesion or increase by ≥50% of previously involved sites from nadir. Nodal masses; Appearance of a new lesion(s) \>1.5 cm in any axis, ≥50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node \>1 cm in short axis. Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Spleen, Liver; ≥50% increase from nadir in the SPD of any previous lesions. Bone marrow; New or recurrent involvement 2. Disease progression during treatment period 3. Disease progression during follow up period 4. Start of treatment of new lesion 5. Occurrence of other multiple malignant tumors 6. Death |
| The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle | — |
| Number of Subjects With Adverse Event | up to 30 weeks | — |
| Number of Adverse Events | up to 30 weeks | — |
| Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values | up to 30 weeks | Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event |
| Number of Subjects With Grade ≥3 Physical Examination Finding | up to 30 weeks | — |
| The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle | — |
| The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle | — |
| The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle | — |
| The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle | — |
| The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle | — |
| The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle | — |
| The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle | — |
| Concomitant Medication Usage | up to 30 weeks | — |
Countries
Japan, South Korea
Participant flow
Pre-assignment details
Among the 63 subjects enrolled in the study, 59 subjects received study drug and four subjects were excluded before the first study drug administration. The reasons for exclusion were adverse events and major protocol deviation/violation for two subjects each.
Participants by arm
| Arm | Count |
|---|---|
| SyB L-0501 SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted. | 59 |
| Total | 59 |
Baseline characteristics
| Characteristic | SyB L-0501 |
|---|---|
| Age Continuous | 64.2 Year STANDARD_DEVIATION 9.2 |
| Age, Customized 20-29 years | 0.0 Percentage of participants |
| Age, Customized 30-39 years | 1.7 Percentage of participants |
| Age, Customized 40-49 years | 8.5 Percentage of participants |
| Age, Customized 50-59 years | 16.9 Percentage of participants |
| Age, Customized 60-69 years | 39.0 Percentage of participants |
| Age, Customized <65 years | 37.3 Percentage of participants |
| Age, Customized ≥65 years | 62.7 Percentage of participants |
| Age, Customized 70-75 years | 33.9 Percentage of participants |
| Body Surface Area（BSA） | 1.537 m^2 STANDARD_DEVIATION 0.184 |
| Bone marrow involvement Indeterminate | 0.0 Percentage of Participants |
| Bone marrow involvement Negative | 94.9 Percentage of Participants |
| Bone marrow involvement Positive | 3.4 Percentage of Participants |
| Bone marrow involvement Unknown | 1.7 Percentage of Participants |
| Clinical Stage (Ann Arbor staging) Stage I | 5.1 Percentage of participants |
| Clinical Stage (Ann Arbor staging) Stage I-E | 3.4 Percentage of participants |
| Clinical Stage (Ann Arbor staging) Stage II | 27.1 Percentage of participants |
| Clinical Stage (Ann Arbor staging) Stage II-E | 3.4 Percentage of participants |
| Clinical Stage (Ann Arbor staging) Stage III | 25.4 Percentage of participants |
| Clinical Stage (Ann Arbor staging) Stage III-E | 3.4 Percentage of participants |
| Clinical Stage (Ann Arbor staging) Stage III-S | 6.8 Percentage of participants |
| Clinical Stage (Ann Arbor staging) Stage III-SE | 0.0 Percentage of participants |
| Clinical Stage (Ann Arbor staging) Stage IV | 25.4 Percentage of participants |
| Clinical Stage (Ann Arbor staging) Unknown | 0.0 Percentage of participants |
| Complications of DLBCL No | 6.8 Percentage of participants |
| Complications of DLBCL Yes | 93.2 Percentage of participants |
| Diagnosis of Relapsed/Refractory Diffuse Large B-Cell Lymphoma | 100.0 percentage of participants |
| Height | 158.25 cm STANDARD_DEVIATION 8.59 |
| International Prognostic Index risk category High-Intermediate (score=3) | 23.6 Percentage of Participants |
| International Prognostic Index risk category High-Intermediate (score≥3) | 30.5 Percentage of Participants |
| International Prognostic Index risk category High(score=4-5) | 6.8 Percentage of Participants |
| International Prognostic Index risk category Low-Intermediate (score=2) | 35.6 Percentage of Participants |
| International Prognostic Index risk category Low-Intermediate (score<3) | 69.5 Percentage of Participants |
| International Prognostic Index risk category Low (score=0-1) | 33.9 Percentage of Participants |
| International Prognostic Index risk category Unknown | 0.0 Percentage of Participants |
| lactate dehydrogenase (LDH) Elevated | 55.9 Percentage of Participants |
| lactate dehydrogenase (LDH) Within normal range | 44.1 Percentage of Participants |
| LDH <240 IU/L | 39.0 Percentage of Participants |
| LDH ≥240 IU/L | 61.0 Percentage of Participants |
| Medical history of diffuse large B-cell lymphoma (DLBCL) No | 40.7 Percentage of participants |
| Medical history of diffuse large B-cell lymphoma (DLBCL) Yes | 59.3 Percentage of participants |
| Number of regimens 1 | 64.4 Percentage of participants |
| Number of regimens 2 | 22.0 Percentage of participants |
| Number of regimens 3 | 13.6 Percentage of participants |
| Prior medication/therapy for DLBCL No | 8.5 Percentage of participants |
| Prior medication/therapy for DLBCL Yes | 91.5 Percentage of participants |
| Prior medication/therapy for DLBCL (Transplant) No | 86.4 Percentage of participants |
| Prior medication/therapy for DLBCL (Transplant) Yes | 13.6 Percentage of participants |
| Prior treatment for DLBCL No | 0.0 Percentage of participants |
| Prior treatment for DLBCL Yes | 100.0 Percentage of participants |
| P.S.(performance status)[the Eastern Cooperative Oncology Group (ECOG) criteria] 0 | 66.1 Percentage of Participants |
| P.S.(performance status)[the Eastern Cooperative Oncology Group (ECOG) criteria] 1 | 33.9 Percentage of Participants |
| Response to prior treatment Non-Responder | 0.0 Percentage of Participants |
| Response to prior treatment Responder | 100.0 Percentage of Participants |
| Response to prior treatment Unknown | 0.0 Percentage of Participants |
| Sex/Gender, Customized Female | 57.6 percentage of participants |
| Sex/Gender, Customized Male | 42.4 percentage of participants |
| Site of disease <2 extranodular sites | 93.2 Percentage of Participants |
| Site of disease ≥4 extranodular sites | 6.8 Percentage of Participants |
| Site of disease <4 nodular sites | 47.5 Percentage of Participants |
| Site of disease ≥4 nodular sites | 52.5 Percentage of Participants |
| Systemic symptoms (B symptoms) (Ann Arbor staging) Asymptomatic | 86.4 Percentage of participants |
| Systemic symptoms (B symptoms) (Ann Arbor staging) Symptomatic | 13.6 Percentage of participants |
| Systemic symptoms (B symptoms) (Ann Arbor staging) Unknown | 0.0 Percentage of participants |
| Time from prior treatment <12 months | 15.3 Percentage of Participants |
| Time from prior treatment ≥12 months | 49.2 Percentage of Participants |
| Time from prior treatment Unknown | 0.0 Percentage of Participants |
| Tumor diameter <5 cm | 71.2 Percentage of Participants |
| Tumor diameter ≥5 cm | 28.8 Percentage of Participants |
| Tumor diameter <7 cm | 86.4 Percentage of Participants |
| Tumor diameter ≥7 cm | 13.6 Percentage of Participants |
| Weight | 57.64 kg STANDARD_DEVIATION 12.85 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 59 / 59 |
| serious Total, serious adverse events | 14 / 59 |
Outcome results
Primary
The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified
Time frame: up to 30 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SyB L-0501 | The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma | 62.7 Percentage of Participants |
Secondary
Concomitant Medication Usage
Time frame: up to 30 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SyB L-0501 | Concomitant Medication Usage | concomitant medications for adverse events | 58 Participants |
| SyB L-0501 | Concomitant Medication Usage | concomitant medications for complications | 50 Participants |
| SyB L-0501 | Concomitant Medication Usage | concomitant medications for supportive therapy | 59 Participants |
| SyB L-0501 | Concomitant Medication Usage | concomitant medications for other reasons | 59 Participants |
Secondary
Number of Adverse Events
Time frame: up to 30 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SyB L-0501 | Number of Adverse Events | Adverse events | 1848 Events |
| SyB L-0501 | Number of Adverse Events | Serious adverse events | 23 Events |
Secondary
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event
Time frame: up to 30 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SyB L-0501 | Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values | Subjects with grade 3 abnormality | 2 Participants |
| SyB L-0501 | Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values | Subjects with grade 4 abnormality | 54 Participants |
Secondary
Number of Subjects With Adverse Event
Time frame: up to 30 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SyB L-0501 | Number of Subjects With Adverse Event | Subjects with adverse event | 59 Participants |
| SyB L-0501 | Number of Subjects With Adverse Event | Subjects with serious adverse event | 14 Participants |
Secondary
Number of Subjects With Grade ≥3 Physical Examination Finding
Time frame: up to 30 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SyB L-0501 | Number of Subjects With Grade ≥3 Physical Examination Finding | Subjects with grade 3 Physical Findings | 1 Participants |
| SyB L-0501 | Number of Subjects With Grade ≥3 Physical Examination Finding | Subjects with grade 4 Physical Findings | 22 Participants |
Secondary
Progression Free Survival (PFS)
PFS = day of the first PFS event - day of start of study treatment + 1 The definitions of PFS event are as below. 1. PD according to overall response on the basis of Revised Response Criteria for Malignant Lymphoma PD: Any new lesion or increase by ≥50% of previously involved sites from nadir. Nodal masses; Appearance of a new lesion(s) \>1.5 cm in any axis, ≥50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node \>1 cm in short axis. Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Spleen, Liver; ≥50% increase from nadir in the SPD of any previous lesions. Bone marrow; New or recurrent involvement 2. Disease progression during treatment period 3. Disease progression during follow up period 4. Start of treatment of new lesion 5. Occurrence of other multiple malignant tumors 6. Death
Time frame: up to 30 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SyB L-0501 | Progression Free Survival (PFS) | 200.0 Days |
Secondary
The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan
Time frame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SyB L-0501 | The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan | 10394.39 ng・h/mL | Standard Deviation 5368.77 |
Secondary
The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea
Time frame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SyB L-0501 | The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea | 9218.56 ng・h/mL | Standard Deviation 6696.81 |
Secondary
The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
The criteria for CR is as below Nodal Masses: 1. fluorodeoxy glucose (FDG)-avid or positron emission tomography (PET) positive prior to therapy; mass of any size permitted if PET negative 2. Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT) Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative
Time frame: up to 30 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SyB L-0501 | The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma | 37.3 Percentage of participants |
Secondary
The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan
Time frame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| SyB L-0501 | The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan | 0.39 hour | Standard Deviation 0.1 |
Secondary
The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea
Time frame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| SyB L-0501 | The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea | 0.48 hour | Standard Deviation 0.18 |
Secondary
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan
Time frame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SyB L-0501 | The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan | 8365.82 ng/mL | Standard Deviation 3522.73 |
Secondary
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea
Time frame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SyB L-0501 | The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea | 8095.99 ng/mL | Standard Deviation 4339.74 |
Secondary
The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan
Time frame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| SyB L-0501 | The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan | 1.0 hour | Standard Deviation 0 |
Secondary
The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea
Time frame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| SyB L-0501 | The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea | 0.9 hour | Standard Deviation 0.3 |