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NCT06474650CompletedPhase 1

Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets

A Randomized, Open-label, Two-period, Double-crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets in Healthy Subjects

Source: ClinicalTrials.gov · Last updated 12 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
16 (actual)
First submitted
20 Jun 2024
Start date
31 Jul 2024
Primary completion date
25 Sept 2024
Lead sponsor
Luye Pharma Group Ltd.
NCT number
NCT06474650

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 16
  • From 31 Jul 2024 to the primary completion date, 25 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
  • 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 used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing;
  • Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
  • Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
  • Subject who has participated in other clinical trials and were enrolled/randomized within 3 months before administration;

Other illness

  • 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 positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
  • Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
  • Subject has a history of substance abuse within 1 year or a positive urine drug screen;
  • Other conditions which would make participation in the study unsuitable

Lab values

  • Subject has abnormal vital signs, laboratory abnormalities, and ECGs;

Other

  • Subject who has daily smoking of ≥ 5 cigarettes within 3 months;
  • Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia
  • Subject has used blood products or being blood donor or blood loss within 3 months;
  • Pregnant, lactating women, or positive pregnancy test;
  • Subject who refusal to contraception, or plan to donate sperm or ovums;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Mental Health Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.