Last reviewed · How we verify
NCT07013773: Y-4-LC-03
A Randomized, Open-label, Single-dose, Two-period, Crossover Phase I Clinical Trial With Two Parallel Arms Evaluating the Impact of Food on the Pharmacokinetics of Y-4 Tablets in Healthy Subjects
Phase 1 trial testing Y-4 tablet in Healthy Male and Female Subjects in 20 participants. Currently enrolling.
1 July 2025
Quick facts
| Lead sponsor | Beijing Tiantan Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 19 May 2025 |
| Primary completion | 1 July 2025 |
| Estimated completion | 1 July 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Y-4 tablet — full drug profile →
Conditions studied
- Healthy Male and Female Subjects — all drugs for Healthy Male and Female Subjects →
Sponsor
Beijing Tiantan Hospital
Who can join
Adults 18 to 45, any sex, with Healthy Male and Female Subjects. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
adverse events
Time frame: 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 -
Incidence of subject getting abnormal results of laboratory tests after treatment
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07013773
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy Male and Female Subjects
Currently open trials in the same condition.
- NCT07144527 — Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults · NA · recruiting
- NCT06825364 — Near-InfraRed Spectroscopy of Auricular Stimulation · NA · recruiting
- NCT06930209 — Histological Analysis of CelluJuve® Injections in the Brachium · NA · active not recruiting
- NCT06974227 — Validation Study of an Assistive Pulse Data Collection Device · Phase 1 · recruiting
- NCT06867679 — Effects of Recreational Soccer Training on Physical Fitness and Gross Motor Coordination in Prepubertal Boys and Girls · NA · recruiting
Other Beijing Tiantan Hospital trials
Trials by the same sponsor.
- NCT07341854 — Dexamethasone Palmitate for Postoperative Pain · NA · not yet recruiting
- NCT07527013 — Stratified Blood Pressure Management Strategy After Endovascular Treatment for Acute Ischemic Stroke · Phase 3 · not yet recruiting
- NCT07520370 — Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor · NA · not yet recruiting
- NCT07526987 — Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis · Phase 3 · not yet recruiting
- NCT07591207 — The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Laparoscopic Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07013773 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tiantan Hospital
- Last refreshed: 6 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07013773.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing