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

NCT04218513 | Completed Phase 1

• 1 other identifier: NJYK-CPEDRV-DDI
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Drug-drug Interaction; Edaravone; 2-Aminoethanesulfonic Acid; Compound Edaravone Injection

Outcome Measures

Primary Outcomes (3)

• Cmax of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid

  24 hours

• AUC0-t of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid

  24 hours

• AUC0-∞ of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid

  24 hours

Study Arms (3)

Compound Edaravone

EXPERIMENTAL

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

Drug: Compound Edaravone Injection

Edaravone

EXPERIMENTAL

30 mL (containing edaravone 30 mg)

Drug: Edaravone Injection

2-Aminoethanesulfonic Acid

EXPERIMENTAL

30 mL (containing 2-aminoethanesulfonic acid 600 mg)

Drug: 2-Aminoethanesulfonic Acid Injection

Interventions

Compound Edaravone Injection DRUG

30 min intravenous infusion

Compound Edaravone

Edaravone Injection DRUG

30 min intravenous infusion

Edaravone

2-Aminoethanesulfonic Acid Injection DRUG

30 min intravenous infusion

2-Aminoethanesulfonic Acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years old (including upper and lower limits);
• Weight ≥50 kg, body mass index (BMI) between 18-28 kg / m2 (including upper and lower limits);
• Understand and sign the informed consent voluntarily, and volunteer to participate in this research.

You may not qualify if:

• A history of diseases of the heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system judged by the investigator as clinically significant;
• 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;
• 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;
• There is a history of food or drug allergy or allergies that the researcher judges to be clinically significant;
• Those with positive results of serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab);
• 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;
• 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;
• As a subject who has participated in any drug clinical trial within 3 months before the first administration of the study;
• Those who donated blood or blood products ≥400 mL or 2 units within three months of the study;
• 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;
• 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;
• 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.

Sponsors & Collaborators

• Nanjing Yoko Biomedical Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Interventions

Edaravone

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three-cycle crossover study

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 6, 2020
• Study Start: May 10, 2019
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

CN (1)