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

An Experiment to Evaluate the Drug-drug Interaction of Formula Edaravone and Formula 2-Aminoethanesulfonic Acid in Compound Edaravone Injection

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

Study Overview

• Status: Completed
• Conditions: Drug-drug Interaction
• Intervention / Treatment: Drug: Compound Edaravone Injection; Drug: Edaravone Injection; Drug: 2-Aminoethanesulfonic Acid Injection

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Compound Edaravone; 30 mL (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg)	Drug: Compound Edaravone Injection; 30 min intravenous infusion
Experimental: Edaravone; 30 mL (containing edaravone 30 mg)	Drug: Edaravone Injection; 30 min intravenous infusion
Experimental: 2-Aminoethanesulfonic Acid; 30 mL (containing 2-aminoethanesulfonic acid 600 mg)	Drug: 2-Aminoethanesulfonic Acid Injection; 30 min intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nanjing Yoko Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Edaravone; Drug-drug Interaction; 2-Aminoethanesulfonic Acid; Compound Edaravone Injection
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: NJYK-CPEDRV-DDI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No