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The primary goal of this clinical trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules and riluzole tablets in the US healthy adult participants after single oral administration under fasted condition.
The secondary goal of the trial is to evaluate the safety and tolerability of Y-4 tablets, pregabalin capsules and riluzole tablets in the US healthy adult participants.
This study will be an open-label, single-dose, three-period study in healthy adult participants. A total of at least 10 participants (about half men and half women) will be will be enrolled and needed to complete in the study. Participants enrolled in this study wil be administered with Y-4 tablets, pregabalin capsules and riluzole tablets at three periods with a 7-day washout.
Periods and corresponding treatments are planned as following:
Period 1: Y-4 tablet, one tablet, 112.5 mg/28.125 mg (pregabalin/riluzole) Period 2: pregabalin capsule, one capsule, 75 mg/capsule Period 3: riluzole tablet, one tablet, 50 mg/tablet
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Y-4 tables | Experimental | In the morning of Day 1 ,single oral administration one Y-4 tablet in the state of fasting state. |
|
| Pregabalin capsule | Experimental | In the morning of Day 8 ,single oral administration one pregabalin capsule in the state of fasting state. |
|
| Riluzole tablet | Experimental | In the morning of Day 15 ,single oral administration one riluzole tablet in the state of fasting state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Y-4 tablet | Drug | Participants will be admitted to research center on Day-1. Participants are required to fast for at least 10 hours prior to dosing on Day 1. In the morning of Day 1, participants will be administered with one tablet of Y-4 (pregabalin 112.5 mg and riluzole 28.125 mg), then participants will be monitored and blood samples will be collected for the following 72 hours (Day4). |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration, it was obtained directly from the measured plasma concentration-time data; | On Day1-4、Day8-11、Day15-18 of observation period. |
| AUC0-t | Area under the concentration-time curve from time zero to the last detectable concentration | On Day1-4、Day8-11、Day15-18 of observation period. |
| AUC0-∞ | Area under the concentration-time curve from time 0 to infinity (extrapolated). | On Day1-4、Day8-11、Day15-18 of observation period. |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time of observed Cmax, it was obtained directly from the measured plasma concentration-time data; | On Day1-4、Day8-11、Day15-18 of observation period. |
| λz | Terminal-phase elimination rate constant, slope of curves terminal segment at semi-log concentration-time curve calculated by linear regression; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Lee | Contact | (201)416-7753 | flee@frontagelab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Clinical Services,Inc. | Secaucus | New Jersey | 07094 | United States |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D019782 | Riluzole |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Pregabalin capsule | Drug | Participants are required to fast for at least 10 hours prior to dosing on Day 8. In the morning of Day 8, participants will be administered with one pregabalin capsule (75 mg pregabalin), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 11). |
|
| Riluzole tablet | Drug | Participants are required to fast for at least 10 hours prior to dosing on Day 15. In the morning of Day 15, participants will be administered with one riluzole tablet (50 mg riluzole), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 18). |
|
| On Day1-4、Day8-11、Day15-18 of observation period. |
| t1/2 | Terminal elimination half-life | On Day1-4、Day8-11、Day15-18 of observation period. |
| CL/F | Apparent total body clearance | On Day1-4、Day8-11、Day15-18 of observation period. |
| Vz/F | Apparent volume of distribution | On Day1-4、Day8-11、Day15-18 of observation period. |
| MRT0-t | Mean residence time within the time from time zero to the lowest testing plasma concentration | On Day1-4、Day8-11、Day15-18 of observation period. |
| MRT0-∞ | Mean residence time extrapolated from zero to infinity | On Day1-4、Day8-11、Day15-18 of observation period. |
| AUC_%Extrap | The percentage of the AUC0-inf that has been extrapolated. | On Day1-4、Day8-11、Day15-18 of observation period. |
| The Incidence of subject getting abnormal results of clinical adverse events after treatment. | An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. All AEs will be coded using the MedDRA, and summarized by SOC and PT. Number and percentage of participants with AEs,SAEs, and AEs that lead to early withdrawal will be summarized. AEs might be summarized by severity (grade) and relationship to investigational product if judged appropriate. | From the first day to the 25th± 1st day after the start of administration |
| The Incidence of subject getting abnormal results of laboratory tests after treatment. | Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment.Clinical laboratory examinations including hematology, serum chemistry, ,urinalysis,coagulation test (PT/APTT/FIB/TT).Normal range is provided by the site. | From the first day to the 25th± 1st day after the start of administration |
| The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment. | Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment.Standard ECG parameters will be measured including RR, PR, and QTc intervals, and QRS duration .Normal range is provided by the site. | From the first day to the 25th± 1st day after the start of administration |
| The Incidence of subject getting abnormal results of vital signs after treatment | Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment.Vital signs, including blood pressure (sitting position), pulse rate, temperature (frontal temperature, Celsius), and respiration.Normal range is provided by the site. | From the first day to the 25th± 1st day after the start of administration |
| The Incidence of subject getting abnormal results of blood oxygen saturation after treatment. | Record changes of blood oxygen saturation from baseline to post-treatment, listing deviations from normal ranges post-treatment. Normal range is provided by the site | From the first day to the 25th± 1st day after the start of administration |
| The Incidence of subject getting abnormal results of physical examinations after treatment. | Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. The physical examinations will consist of a general assessment, dermatologic, lymph nodes, head, eyes, ears, nose, throat, chest, neck, thyroid gland, cardiac, lung, chest (included breast), abdomen, extremities, musculoskeletal, neurologic, and other physical findings of note. Normal range is provided by the site. | From the first day to the 25th± 1st day after the start of administration |
| The Incidence of subject getting abnormal results of C-SSRS scale evaluation after treatment. | Record changes of C-SSRS scale evaluation from baseline to post-treatment. | From the first day to the 25th± 1st day after the start of administration |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D052160 | Benzothiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |