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Completed

NCT Number: NCT04218513

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Compound Edaravone Injection

Drug

30 min intravenous infusion

Edaravone Injection

Drug

30 min intravenous infusion

2-Aminoethanesulfonic Acid Injection

Drug

30 min intravenous infusion

Primary outcomes

  1. Cmax of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid

    Time frame: 24 hours

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

    Time frame: 24 hours

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

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Nanjing Yoko Biomedical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 6, 2020
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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