Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBeijing Tiantan Hospital
About this trial
Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.
The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose.
The secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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));
Trial design
Treatments tested in this trial
- Y-4 tables
- Y-4 placebos
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
Neurodawn Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov