Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets (NCT06474650) | Clinical Trial Compass
CompletedPhase 1
Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets
China16 participantsStarted 2024-07-31
Plain-language summary
This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164 sustained-release tablets 30 mg in healthy subjects.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Subject who voluntarily participate and sign the informed consent form;
✓. Healthy male/female volunteers aged 18 to 45 years;
✓. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 \~ 26.0 kg/m2, inclusive;
✓. Able to comply with the lifestyle restrictions.
Exclusion criteria
✕. Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
✕. Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
✕. Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
✕. Subject has a history of self-mutilation; or at risk of suicide;
✕. Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
✕. Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
What they're measuring
1
Peak Plasma Concentration (Cmax)
Timeframe: Predose and up to 240 hours postdose
2
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)
Timeframe: Predose and up to 240 hours postdose
3
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)
✕. Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing;
✕. Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);