A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

NCT ID: NCT04627155

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-15
• Study Completion Date: 2013-05-20

Brief Summary

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

Conditions

Parkinson Disease

Keywords

LY03003

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

7mg dose group

Group Type: EXPERIMENTAL

LY03003

Intervention Type: DRUG

Rotigotine,extended-release microspheres

14mg dose group

Group Type: EXPERIMENTAL

LY03003

Intervention Type: DRUG

Rotigotine,extended-release microspheres

Interventions

LY03003

Rotigotine,extended-release microspheres

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. aged 18 to 45 years, no less than one-third of a single sex ratio;

2. 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);

3. body weight not less than 50 kg, body mass index between 19 and 24 kg/m2;

4. during 2 weeks not using any drugs;

5. no history of drug allergy or drug allergy;

6. voluntarily participate in this clinical trial, can cooperate to complete the specified examinations, and sign the informed consent form

Exclusion Criteria

1. abnormal health examination and clinical significance;

2. history of allergy to non-ergot dopamine agonists, or history of allergy to other drugs and food;

3. Bronchial asthma, epilepsy, mechanical intestinal obstruction, urinary tract obstruction;

4. history of liver and kidney disease, cardiovascular system, respiratory system, hematopoietic system, nervous and mental illness;

5. 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;

6. lactating women;

7. 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;

8. smokers, alcoholics and drug abusers;

9. drinkers within 24 hours before medication;

10. 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;

13. Researchers believe that the participants are not suitable.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LY03003/CT-CHN-101

Identifier Type: -

Identifier Source: org_study_id