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

• Sponsor: Nanjing Yoko Biomedical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04218513
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Actual Duration (Days): 21
• Patients Per Site Per Month: 34.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Drug-drug Interaction	Drug: Compound Edaravone Injection; Drug: Edaravone Injection; Drug: 2-Aminoethanesulfonic Acid Injection	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Three-cycle crossover studyThree-cycle crossover study
• Masking: None (Open Label)
• Masking Description: Open Label
• Primary Purpose: Basic Science
• Official Title: An Experiment to Evaluate the Drug-drug Interaction of Formula Edaravone and Formula 2-Aminoethanesulfonic Acid in Compound Edaravone Injection
• Actual Study Start Date: May 10, 2019
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cmax of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid [24 hours]

2. AUC0-t of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid [24 hours]

3. AUC0-∞ of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing	China	100050

Sponsors and Collaborators

• Nanjing Yoko Biomedical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nanjing Yoko Biomedical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04218513
• Other Study ID Numbers: NJYK-CPEDRV-DDI
• First Posted: Jan 6, 2020
• Last Update Posted: Mar 22, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nanjing Yoko Biomedical Co., Ltd.: Drug-drug Interaction; Edaravone; 2-Aminoethanesulfonic Acid; Compound Edaravone Injection
• Additional relevant MeSH terms: Edaravone

Study Results

No Results Posted as of Mar 22, 2021