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Completed

NCT Number: NCT04627155

A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

This study is to evaluate the human tolerance and pharmacokinetics of LY03003.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 18 to 45 years, no less than one-third of a single sex ratio;
  • normal physical examination items (including general physical examination, blood and urine, blood biochemistry, anti-HBV, anti-HCV, anti-HIV, pregnancy test, ECG, chest X-ray);
  • body weight not less than 50 kg, body mass index between 19 and 24 kg/m2;
  • during 2 weeks not using any drugs;
  • no history of drug allergy or drug allergy;
  • voluntarily participate in this clinical trial, can cooperate to complete the specified examinations, and sign the informed consent form

Exclusion criteria

  • abnormal health examination and clinical significance;
  • history of allergy to non-ergot dopamine agonists, or history of allergy to other drugs and food;
  • Bronchial asthma, epilepsy, mechanical intestinal obstruction, urinary tract obstruction;
  • history of liver and kidney disease, cardiovascular system, respiratory system, hematopoietic system, nervous and mental illness;
  • Women of childbearing age who have a positive pregnancy test or a negative pregnancy test but cannot ensure to take appropriate contraceptive measures during the study;
  • lactating women;
  • Male subjects who are unwilling to take appropriate contraceptive measures. Appropriate measures include the use of condoms, spermicides, or female partners using intrauterine devices (IUDs), ovarian caps, oral contraceptives, injected or subcutaneously implanted progestins, and tubal ligation surgery. Female partners must not be pregnant or lactating women;
  • smokers, alcoholics and drug abusers;
  • drinkers within 24 hours before medication;
  • used any drugs within 2 weeks before the trial; Use of drugs with effect on liver and kidney function within 11.3 months; Participated in other drug trials within 12.3 months, donated blood loss (≥ 200ml), or sampled as subjects;
  • Researchers believe that the participants are not suitable.

Treatment and study plan

LY03003

Drug

Rotigotine,extended-release microspheres

Primary outcomes

  1. Plasma drug concentration

    Time frame: Hour1 、Hour6、Hour12、Hour24、Hour36、Hour48、Hour60 、Hour72 、Hour84、Hour96 、Hour120 、Hour144 、Day8、Day9、Day10、Day11、Day12、Day13、Day14、Day16、Day18 and Day 21after injection

    Cmax

Secondary outcomes

  1. Vital signs

    Time frame: Hour1 、Hour6、Hour12、Hour24、Hour36、Hour48、Hour60 、Hour72 、Hour84、Hour96 、Hour120 、Hour144 、Day8、Day9、Day10、Day11、Day12、Day13、Day14、Day16、Day18 and Day 21after injection

    Blood pressure

  2. Vital signs

    Time frame: Hour1 、Hour6、Hour12、Hour24、Hour36、Hour48、Hour60 、Hour72 、Hour84、Hour96 、Hour120 、Hour144 、Day8、Day9、Day10、Day11、Day12、Day13、Day14、Day16、Day18 and Day 21after injection

    Weight

Sponsors and collaborators

Lead sponsor

Luye Pharma Group Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular Injection

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 13, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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