Drug-drug InteractionPhase 1NCT04218513

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

A Phase 1 study testing Compound Edaravone Injection, Edaravone Injection and 2-Aminoethanesulfonic Acid Injection in people with Drug-drug Interaction, run by Nanjing Yoko Biomedical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An experiment to evaluate the drug-drug interaction of formula edaravone and formula 2-aminoethanesulfonic acid in compound edaravone injection. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Drug-drug Interaction
What is being tested?: Compound Edaravone Injection, Edaravone Injection and 2-Aminoethanesulfonic Acid Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 10 May 2019to 31 May 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050

Other trials in China

About this study

Official title: 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.

Conditions: Drug-drug Interaction
Being tested: Compound Edaravone Injection, Edaravone Injection, 2-Aminoethanesulfonic Acid Injection
Keywords: Drug-drug Interaction, Edaravone, 2-Aminoethanesulfonic Acid, Compound Edaravone Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Compound Edaravone InjectionDrug
30 min intravenous infusion
Edaravone InjectionDrug
30 min intravenous infusion
2-Aminoethanesulfonic Acid InjectionDrug
30 min intravenous infusion

Study groups in NCT04218513
Study group	Role	What they receive
Compound Edaravone	Experimental	30 mL (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg) Receives: Drug: Compound Edaravone Injection
Edaravone	Experimental	30 mL (containing edaravone 30 mg) Receives: Drug: Edaravone Injection
2-Aminoethanesulfonic Acid	Experimental	30 mL (containing 2-aminoethanesulfonic acid 600 mg) Receives: Drug: 2-Aminoethanesulfonic Acid Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid
Measured: 24 hours
AUC0-t of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid
Measured: 24 hours
AUC0-∞ of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 201931 May 2019

First posted6 Jan 2020
Study start10 May 2019
Primary completion31 May 2019
Study completion31 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Drug-drug InteractionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Three-cycle crossover study
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04218513
Sponsor's protocol ID: NJYK-CPEDRV-DDI
Status last verified: Mar 2021
First submitted: 17 Dec 2019
Last updated: 22 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Experiment to Evaluate the Drug-drug Interaction of Formula Edaravone and Formula 2-Aminoethanesulfonic Acid in Compound Edaravone Injection
ClinicalTrials.gov ID: NCT04218513
Acronym / sponsor ID: NJYK-CPEDRV-DDI
Conditions: Drug-drug Interaction
Keywords: Drug-drug Interaction, Edaravone, 2-Aminoethanesulfonic Acid, Compound Edaravone Injection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Nanjing Yoko Biomedical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 May 2019 (actual)
Primary completion: 31 May 2019 (actual)
Study completion: 31 May 2019 (actual)
First posted: 6 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: Three-cycle crossover study

Arm	Type	Receives
Compound Edaravone	Experimental	Drug: Compound Edaravone Injection30 mL (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg)
Edaravone	Experimental	Drug: Edaravone Injection30 mL (containing edaravone 30 mg)
2-Aminoethanesulfonic Acid	Experimental	Drug: 2-Aminoethanesulfonic Acid Injection30 mL (containing 2-aminoethanesulfonic acid 600 mg)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (12 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Compound Edaravone Injection30 min intravenous infusion	Drug	Compound Edaravone
Edaravone Injection30 min intravenous infusion	Drug	Edaravone
2-Aminoethanesulfonic Acid Injection30 min intravenous infusion	Drug	2-Aminoethanesulfonic Acid

Primary outcome

Cmax of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid
Time frame: 24 hours
AUC0-t of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid
Time frame: 24 hours
AUC0-∞ of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.

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RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of edaravone with and without coIntravenous with 2-Aminoethanesulfonic Acid (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04218513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.