Drug-drug Interaction Study Between Edaravone and 2-Aminoethanesulfonic Acid in Compound Edaravone Injection

NCT ID: NCT04218513

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2019-05-31

Brief Summary

An experiment to evaluate the drug-drug interaction of formula edaravone and formula 2-aminoethanesulfonic acid in compound edaravone injection.

Conditions

Drug-drug Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Compound Edaravone

30 mL (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg)

Group Type: EXPERIMENTAL

Compound Edaravone Injection

Intervention Type: DRUG

30 min intravenous infusion

Edaravone

30 mL (containing edaravone 30 mg)

Group Type: EXPERIMENTAL

Edaravone Injection

Intervention Type: DRUG

30 min intravenous infusion

2-Aminoethanesulfonic Acid

30 mL (containing 2-aminoethanesulfonic acid 600 mg)

Group Type: EXPERIMENTAL

2-Aminoethanesulfonic Acid Injection

Intervention Type: DRUG

30 min intravenous infusion

Interventions

Compound Edaravone Injection

30 min intravenous infusion

Intervention Type: DRUG

Edaravone Injection

30 min intravenous infusion

Intervention Type: DRUG

2-Aminoethanesulfonic Acid Injection

30 min intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age: 18-65 years old (including upper and lower limits);

2. Weight ≥50 kg, body mass index (BMI) between 18-28 kg / m2 (including upper and lower limits);

3. Understand and sign the informed consent voluntarily, and volunteer to participate in this research.

Exclusion Criteria

1. A history of diseases of the heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system judged by the investigator as clinically significant;

2. A comprehensive physical examination, neurological examination, laboratory examination, ECG examination, or cognitive assessment indicates that the subject has an abnormality that the researcher has determined to be clinically significant;

3. Have taken any drug within two weeks before the study administration, and the researcher believes that this situation may affect the evaluation results of this study;

4. There is a history of food or drug allergy or allergies that the researcher judges to be clinically significant;

5. Those with positive results of serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab);

6. A history of alcohol or drug abuse that the investigator believes may affect the evaluation results of this study within one year before the study administration;

7. Cannot quit smoking or drinking during the study period or the carbon monoxide breath test> 7 ppm during the screening period CO breath test, so if the subject's CO breath is> 7ppm, but the urine cotinine test is negative, it means that the CO breath test result may be false positive, the subject can be enrolled;

8. As a subject who has participated in any drug clinical trial within 3 months before the first administration of the study;

9. Those who donated blood or blood products ≥400 mL or 2 units within three months of the study;

10. Do not agree to avoid the use of tobacco, alcohol or caffeinated beverages, or vigorous exercise, or other factors that affect drug absorption, distribution, metabolism, excretion, etc. during the 24 hours before and during the test;

11. Pregnant or lactating women, or those who tested positive for serum HCG before the test administration, or those who were unable or unwilling to take researcher-approved contraception during the study according to the researcher's instructions;

12. Subjects with poor compliance or unable to comply with the relevant provisions of the research protocol due to personal reasons, the investigator judges that the subjects are not suitable to participate in this clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Yoko Biomedical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

NJYK-CPEDRV-DDI

Identifier Type: -

Identifier Source: org_study_id