Healthy AdultsPhase 1NCT05330000

Comparative Study on Tolerance and Pharmacokinetics of Voriconazole for Injection in Healthy Subjects

A Phase 1 study testing 4 mg/kg Voriconazole and 6 mg/kg Voriconazole in people with Healthy Adults, run by The Affiliated Hospital of Qingdao University 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

Search all trials

Trial summary

A single intravenous drip of voriconazole for injection developed by Qilu Pharmaceutical (Hainan) Co., Ltd. and the original product "vfend" was given to healthy subjects ， The pharmacokinetic differences and tolerance of the two preparations were evaluated at the doses of 4mg / kg and 6mg / kg. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adults
What is being tested?: 4 mg/kg Voriconazole and 6 mg/kg Voriconazole
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteChina
Study dates: 22 May 2020to 16 Sep 2020
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1) Chinese healthy adult male and female subjects aged 18-45 years (including 18 and 45 years);
2) The weight of male subjects shall not be less than 50kg and that of female subjects shall not be less than 45kg. Body mass index (BMI)= body weight (kg) / height 2 (M2), body mass index in the range of 19 ~ 28 kg / m2 (including critical value);
3) Good health: no heart, liver, kidney, digestive tract, endocrine, blood system, respiratory system and nervous systemMedical history of general, mental and metabolic abnormalities, physical examination, ECG, vital signs evaluation and experiment. The laboratory examination and other relevant examinations are normal or abnormal, have no clinical significance, and are judged as qualified by the research doctor (creatinine is not higher than the upper limit of normal value and / or liver function (alanine aminotransferase, aspartate aminotransferase, bilirubin) Not more than 1.5 × ULN）；
4) The subjects had no family planning and were able to take effective contraceptive measures within 6 months from the screening of the trial to the end of the study;
5) Voluntarily sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions Solution;
6) Be able to complete the research according to the requirements of the test scheme.

Who cannot join

1) Persons with specific allergic history (asthma, urticaria, eczema, etc.), or allergic constitution (such as for two or more drugsAllergic to food such as milk or pollen), or known allergic to this drug or similar components.
2) The screening results of infectious diseases (HIV antibody, hepatitis B surface antigen, hepatitis C antibody and syphilis antibody) were positive.
3) Female subjects in the screening period or clinical trials are in lactation or pregnancy test results are positive, or screening Whether there is protective behavior in the first 2 weeks.
4) Urine drug screening results were positive.
5) Those who have a history of drug abuse in the past five years or have used drugs in the first three months of screening.
6) Regular drinkers within 6 months before screening (regular drinkers are defined as drinking more than 2 units per day, or Drinking more than 14 units of alcohol a week; 1 unit = 360 ml of beer or 45 ml of 40% alcohol Wine or 150 ml wine).

Show all 20Show fewer

7) Those who smoked more than 5 cigarettes a day three months before screening.
8) Blood donation or massive blood loss (> 400 ml, except physiological blood loss in women) within three months before screening.
9) Those who have a history of hospitalization or surgery within three months before screening.
10) Those who took clinical trial drugs within three months before screening.
11) Any prescription drug was taken within 14 days before taking the study drug.
12) Took any over-the-counter drugs or herbal products within 48 hours before taking the study drug.
13) Ingestion of grapefruit fruit or products containing grapefruit ingredients within 72 hours before taking the study drug.
14) Those who ingested beverages or foods rich in caffeine or xanthine (such as coffee, strong tea, chocolate, coke, etc.) within 48 hours before taking the study medication, or took any alcoholic products or had positive alcohol breath test results.
15) Any drugs that inhibit or induce the metabolism of drugs in the liver within 30 days before screening (such as inducers barbiturates, carbamazepine, phenytoin, glucocorticoids, Omeprazole; inhibitors SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.).
16) Those who have special requirements for diet and cannot follow the unified diet (such as intolerable to standard food, etc.).
17) Have a history of needle syncope, blood syncope or known severe bleeding factors that can affect venous blood collection.
18) Those who have difficulty in intravenous drip administration.
19) Acute disease occurred during the pre study screening phase or before study medication.
20) According to the judgment of the researcher, it is not suitable to participate in this experiment.

Trial locations and contacts

1 site in 1 country.

China1 site

Phase I Clinical Research Center
Qingdao, Shanndong, 266003

Other trials in China

About this study

Read the detailed description

Low dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole (T) for injection or reference preparation vfend ® (R) in fasting state per cycle. The dosage was 4 mg / kg for 80 min;After a 7-day cleaning period, the second cycle of cross administration.

High dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole (T) for injection or reference preparation vfend ® (R) in fasting state per cycle. The dosage was 6 mg / kg for 120 min;After a 7-day cleaning period, the second cycle of cross administration.

Conditions: Healthy Adults
Being tested: 4 mg/kg Voriconazole, 6 mg/kg Voriconazole
Keywords: Voriconazole, Pharmacokinetics, Tolerance

What participants receive

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

4 mg/kg VoriconazoleDrug
Low dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole for injection in fasting state per cycle. The dosage was 4 mg / kg for 80 min.
6 mg/kg VoriconazoleDrug
High dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole for injection in fasting state per cycle. The dosage was 6 mg / kg for 120 min.

Study groups in NCT05330000
Study group	Role	What they receive
Voriconazole (R)	Active comparator	Not described Receives: Drug: 4 mg/kg Voriconazole; Drug: 6 mg/kg Voriconazole
Voriconazole (T)	Experimental	Not described Receives: Drug: 4 mg/kg Voriconazole; Drug: 6 mg/kg Voriconazole

What is being measured

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

AUC0-t
17 tubes (3ml / tube) of venous blood were collected in the low dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.33h (80min, at the end of administration), 1.42h (85min), 1.5h, 1.75h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration.
18 tubes (3ml / tube) of venous blood were collected in the high-dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.5h, 1.75h, 2.0h (at the end of administration), 2.08h (125min), 2.17h (130min), 2.33h (140min), 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration.
The plasma concentration of voriconazole was determined by LC-MS / MS. Winnonlin ® 6.4 calculate the pharmacokinetic parameters.
Measured: ± 1 minute within 4 hours. ± 3 minutes for 4-12 hours. ± 5 minutes for more than 12 hours.
AUC0-∞
17 tubes (3ml / tube) of venous blood were collected in the low dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.33h (80min, at the end of administration), 1.42h (85min), 1.5h, 1.75h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration.
18 tubes (3ml / tube) of venous blood were collected in the high-dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.5h, 1.75h, 2.0h (at the end of administration), 2.08h (125min), 2.17h (130min), 2.33h (140min), 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration.
The plasma concentration of voriconazole was determined by LC-MS / MS. Winnonlin ® 6.4 calculate the pharmacokinetic parameters.
Measured: ± 1 minute within 4 hours. ± 3 minutes for 4-12 hours. ± 5 minutes for more than 12 hours.
Cmax
17 tubes (3ml / tube) of venous blood were collected in the low dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.33h (80min, at the end of administration), 1.42h (85min), 1.5h, 1.75h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration.
18 tubes (3ml / tube) of venous blood were collected in the high-dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.5h, 1.75h, 2.0h (at the end of administration), 2.08h (125min), 2.17h (130min), 2.33h (140min), 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration.
The plasma concentration of voriconazole was determined by LC-MS / MS. Winnonlin ® 6.4 calculate the pharmacokinetic parameters.
Measured: ± 1 minute within 4 hours. ± 3 minutes for 4-12 hours. ± 5 minutes for more than 12 hours.
Tmax
17 tubes (3ml / tube) of venous blood were collected in the low dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.33h (80min, at the end of administration), 1.42h (85min), 1.5h, 1.75h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration.
18 tubes (3ml / tube) of venous blood were collected in the high-dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.5h, 1.75h, 2.0h (at the end of administration), 2.08h (125min), 2.17h (130min), 2.33h (140min), 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration.
The plasma concentration of voriconazole was determined by LC-MS / MS. Winnonlin ® 6.4 calculate the pharmacokinetic parameters.
Measured: ± 1 minute within 4 hours. ± 3 minutes for 4-12 hours. ± 5 minutes for more than 12 hours.

Secondary outcomes (2)

Adverse event
All adverse events (clinical symptoms, signs or diseases) occurring during the test (including cleaning period) shall be recorded in the source file. The signs and symptoms, occurrence date and time, duration, end date and time, measures taken and follow-up of adverse events shall also be recorded.
Measured: Up to two years.
female pregnancy test
Urine pregnancy examination was performed during the screening period. Blood pregnancy tests were performed at the end of the study or early termination of the trial.
Measured: Day 16 after administration.

Timeline

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

22 May 202016 Sep 2020

First posted15 Apr 2022
Study start22 May 2020
Primary completion8 Jul 2020
Study completion16 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy AdultsStudies of the same condition, open and under way.
More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: A total of 48 healthy adult subjects were enrolled; Intravenous drip Voriconazole (T) for injection or reference preparation vfend ® （R）in fasting state per cycle； After a 7-day cleaning period, the second cycle of cross administration.
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05330000
Sponsor's protocol ID: QL-YZ1-004-001
Status last verified: Apr 2022
First submitted: 21 Feb 2022
Last updated: 15 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Li X, Wang C, Shi P, Liu Y, Tao Y, Lin P, Li T, Hu H, Sun F, Liu S, Fu Y, Cao Y. Pharmacokinetics and safety of two Voriconazole formulations after intravenous infusion in two doses in healthy Chinese subjects. BMC Pharmacol Toxicol. 2023 Mar 3;24(1):14. doi: 10.1186/s40360-023-00652-3.
PubMed 36869387

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?

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All Healthy Adults trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study on Tolerance and Pharmacokinetics of Voriconazole for Injection in Healthy Subjects
ClinicalTrials.gov ID: NCT05330000
Acronym / sponsor ID: QL-YZ1-004-001
Conditions: Healthy Adults
Keywords: Voriconazole, Pharmacokinetics, Tolerance
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
Study start: 22 May 2020 (actual)
Primary completion: 8 Jul 2020 (actual)
Study completion: 16 Sep 2020 (actual)
First posted: 15 Apr 2022 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: A total of 48 healthy adult subjects were enrolled; Intravenous drip Voriconazole (T) for injection or reference preparation vfend ® （R）in fasting state per cycle； After a 7-day cleaning period, the second cycle of cross administration.

Arm	Type	Receives
Voriconazole (R)	Active comparator	Drug: 4 mg/kg Voriconazole, Drug: 6 mg/kg Voriconazole
Voriconazole (T)	Experimental	Drug: 4 mg/kg Voriconazole, Drug: 6 mg/kg Voriconazole

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

1) Chinese healthy adult male and female subjects aged 18-45 years (including 18 and 45 years);
2) The weight of male subjects shall not be less than 50kg and that of female subjects shall not be less than 45kg. Body mass index (BMI)= body weight (kg) / height 2 (M2), body mass index in the range of 19 ~ 28 kg / m2 (including critical value);
3) Good health: no heart, liver, kidney, digestive tract, endocrine, blood system, respiratory system and nervous systemMedical history of general, mental and metabolic abnormalities, physical examination, ECG, vital signs evaluation and experiment. The laboratory examination and other relevant examinations are normal or abnormal, have no clinical significance, and are judged as qualified by the research doctor (creatinine is not higher than the upper limit of normal value and / or liver function (alanine aminotransferase, aspartate aminotransferase, bilirubin) Not more than 1.5 × ULN）；
4) The subjects had no family planning and were able to take effective contraceptive measures within 6 months from the screening of the trial to the end of the study;
5) Voluntarily sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions Solution;

Key exclusion criteria (20 listed)

1) Persons with specific allergic history (asthma, urticaria, eczema, etc.), or allergic constitution (such as for two or more drugsAllergic to food such as milk or pollen), or known allergic to this drug or similar components.
2) The screening results of infectious diseases (HIV antibody, hepatitis B surface antigen, hepatitis C antibody and syphilis antibody) were positive.
3) Female subjects in the screening period or clinical trials are in lactation or pregnancy test results are positive, or screening Whether there is protective behavior in the first 2 weeks.
4) Urine drug screening results were positive.
5) Those who have a history of drug abuse in the past five years or have used drugs in the first three months of screening.

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
4 mg/kg VoriconazoleLow dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole for injection in fasting state per cycle. The dosage was 4 mg / kg for 80 min.	Drug	Voriconazole (R), Voriconazole (T)
6 mg/kg VoriconazoleHigh dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole for injection in fasting state per cycle. The dosage was 6 mg / kg for 120 min.	Drug	Voriconazole (R), Voriconazole (T)

Primary outcome

AUC0-t
Time frame: ± 1 minute within 4 hours. ± 3 minutes for 4-12 hours. ± 5 minutes for more than 12 hours.
17 tubes (3ml / tube) of venous blood were collected in the low dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.33h (80min, at the end of administration), 1.42h (85min), 1.5h, 1.75h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration. 18 tubes (3ml / tube) of venous blood were collected in the high-dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.5h, 1.75h, 2.0h (at the end of administration), 2.08h (125min), 2.17h (130min), 2.33h (140min), 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration. The plasma concentration of voriconazole was determined by LC-MS / MS. Winnonlin ® 6.4 calculate the pharmacokinetic parameters.
AUC0-∞
Time frame: ± 1 minute within 4 hours. ± 3 minutes for 4-12 hours. ± 5 minutes for more than 12 hours.
17 tubes (3ml / tube) of venous blood were collected in the low dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.33h (80min, at the end of administration), 1.42h (85min), 1.5h, 1.75h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration. 18 tubes (3ml / tube) of venous blood were collected in the high-dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.5h, 1.75h, 2.0h (at the end of administration), 2.08h (125min), 2.17h (130min), 2.33h (140min), 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration. The plasma concentration of voriconazole was determined by LC-MS / MS. Winnonlin ® 6.4 calculate the pharmacokinetic parameters.
Cmax
Time frame: ± 1 minute within 4 hours. ± 3 minutes for 4-12 hours. ± 5 minutes for more than 12 hours.
17 tubes (3ml / tube) of venous blood were collected in the low dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.33h (80min, at the end of administration), 1.42h (85min), 1.5h, 1.75h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration. 18 tubes (3ml / tube) of venous blood were collected in the high-dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.5h, 1.75h, 2.0h (at the end of administration), 2.08h (125min), 2.17h (130min), 2.33h (140min), 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration. The plasma concentration of voriconazole was determined by LC-MS / MS. Winnonlin ® 6.4 calculate the pharmacokinetic parameters.
Tmax
Time frame: ± 1 minute within 4 hours. ± 3 minutes for 4-12 hours. ± 5 minutes for more than 12 hours.
17 tubes (3ml / tube) of venous blood were collected in the low dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.33h (80min, at the end of administration), 1.42h (85min), 1.5h, 1.75h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration. 18 tubes (3ml / tube) of venous blood were collected in the high-dose group. 3ml of venous blood was collected from the contralateral upper arm at 0:00 (within 1 hour before administration) and 0.50h, 1.0h, 1.5h, 1.75h, 2.0h (at the end of administration), 2.08h (125min), 2.17h (130min), 2.33h (140min), 2.5h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, 24.0h, 36.0h and 48.0h after administration. The plasma concentration of voriconazole was determined by LC-MS / MS. Winnonlin ® 6.4 calculate the pharmacokinetic parameters.

2 secondary outcomes

Adverse event
Time frame: Up to two years.
female pregnancy test
Time frame: Day 16 after administration.

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 15 Apr 2022.
Derived from this study: PubMed 36869387Li X, Wang C, Shi P, Liu Y, Tao Y, Lin P, Li T, Hu H, Sun F, Liu S, Fu Y, Cao Y. Pharmacokinetics and safety of two Voriconazole formulations after intravenous infusion in two doses in healthy Chinese subjects. BMC Pharmacol Toxicol. 2023 Mar 3;24(1):14. doi: 10.1186/s40360-023-00652-3.

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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.

Yu Cao, Doctor principal investigator

National Medical Products Administration

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 4 mg/kg Voriconazole and 6 mg/kg Voriconazole in people with Healthy Adults, run by The Affiliated Hospital of Qingdao University at 1 site in China.

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 6 inclusion and 20 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 15 Apr 2022. 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?

AUC0-t (time frame: ± 1 minute within 4 hours. ± 3 minutes for 4-12 hours. ± 5 minutes for more than 12 hours.). The study lists 4 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 NCT05330000, which also lists 1 linked publication.

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 15 Apr 2022.