A Phase 1 interventional study of Y-4 tablet and Pregabalin capsule in Healthy Male and Female Subjects, sponsored by Neurodawn Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Neurodawn Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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
196 studies on the registry are indexed under Neuralgia, Postherpetic; 28 are open to participants now.
This study's planned enrollment of 11 is below the median of 94 across 162 interventional studies indexed under Neuralgia, Postherpetic.
Browse Neuralgia, Postherpetic studies →Neurodawn Pharmaceutical Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the morning of Day 1 ，single oral administration one Y-4 tablet in the state of fasting state.
Drug: Y-4 tablet
In the morning of Day 8 ，single oral administration one pregabalin capsule in the state of fasting state.
Drug: Pregabalin capsule
In the morning of Day 15 ，single oral administration one riluzole tablet in the state of fasting state.
Drug: Riluzole tablet
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).
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).
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).
Cmax
Maximum observed concentration, it was obtained directly from the measured plasma concentration-time data;
Time frame: 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
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
AUC0-∞
Area under the concentration-time curve from time 0 to infinity (extrapolated).
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
Tmax
Time of observed Cmax, it was obtained directly from the measured plasma concentration-time data;
Time frame: 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;
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
t1/2
Terminal elimination half-life
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
CL/F
Apparent total body clearance
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
Vz/F
Apparent volume of distribution
Time frame: 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
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
MRT0-∞
Mean residence time extrapolated from zero to infinity
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
AUC_%Extrap
The percentage of the AUC0-inf that has been extrapolated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From the first day to the 25th± 1st day after the start of administration
Plan to share: No
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Studies of the drugs tested here: Pregabalin · Riluzole
Neurodawn Pharmaceutical Co., Ltd. →