Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.
The objective is to assess the effect of food on the pharmacokinetics (PK) of pregabalin and riluzole in healthy adult subjects after a single oral dose of Y-4 tablets.
Healthy adult male and female subjects, 18-45 years of age (including both ends).
Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2 (including both ends).
During the screening period, serum creatinine is within the normal range, or the standard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80 mL/min (for female subject, according to the calculation result × 0.85）.
Subjects who are able to understand and give their signed informed consent before any trial related procedures are performed.
Subjects who are known to be allergic to pregabalin, riluzole or any excipients of Y-4 tablets (microcrystalline cellulose, Copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry amb Ⅱ), have allergic diseases or allergic constitution;
Subjects who have special requirements for diet and cannot follow the unified diet;
Physical examinations, vital signs, 12-lead electrocardiograms (ECG), chest X-ray (front position), laboratory tests (hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;
Subjects who have experienced angioedema in the past (such as swelling of the face, mouth (tongue, lips, and gums), and neck (pharynx and throat));
Crossover
Y-4 tablet
DrugThe enrolled subjects will be randomly divided into group AB and group BA, with a total of 10 subjects in each group, all subjects will take one Y-4 tablet (pregabalin 112.5 mg, riluzole 28.125 mg) at each period. Subjects of group AB will take Y-4 tablet under fasted condition in period 1, and take Y-4 tablet under fed condition in period 2. In contrast, subjects of group BA will take Y-4 tablet under fed condition in period 1, and take Y-4 tablet under fasted condition in period 2. There will be 7 days of wash-out between the two periods.
adverse events
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. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment. The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of "mild", "moderate" and "severe". The relevance evaluation is divided into 5 grades: 1-certainly related; 2- probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
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. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Incidence of subject getting abnormal results of 12-lead ECG after treatment
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
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(body temperature, respiration, blood pressure, and pulse) will be assessed by according equipment.(electronic sphygmomanometer, thermometer).
Cmax
peak plasma concentration after single dose
AUC0-t
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration after single dose
AUC0-∞
Area under the plasma concentration-time curve from time 0 to infinity (extrapolated) after single dose
Tmax
Time to reach maximum observed plasma concentration after single dose
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Beijing Tiantan Hospital
Lead sponsor
Neurodawn Pharmaceutical Co., Ltd.
Collaborator
