To Evaluate the Effect of Food on the Pharmacokinetics of Y-4 Tablets in Healthy Subjects
Condition(s) studied
Investigational drug(s) / intervention(s)
Y-4 tablet: The 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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- adverse events — From the first day to the 19th± 1st day after the start of administration
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 — From the first day to the 19th± 1st day after the start of administration
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 — From the first day to the 19th± 1st day after the start of administration
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. — From the first day to the 19th± 1st day after the start of administration
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). - Incidence of subject getting abnormal results of physical examinations after treatment. — From the first day to the 19th± 1st day after the start of administration
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation. - Incidence of subject getting abnormal results of blood oxygen saturation after treatment — rom the first day to the 19th± 1st day after the start of administration
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 - Incidence of subject getting abnormal results of C-SSSRS scale evaluation after treatment after treatment — From the first day to the 19th± 1st day after the start of administration
Record changes of C-SSSRS scale evaluation from baseline to post-treatment
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University Beijing | Beijing | Beijing Municipality | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07013773 on ClinicalTrials.gov ↗ ← All trials in China