BioequivalencePhase 1NCT04753489
Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions
A Phase 1 study testing Rivaroxaban film-coated tablet 10 mg and Xarelto® film-coated tablet 10 mg in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Russia.
Trial summary
This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test (Rivaroxaban, 10 mg film-coated tablets) formulation in each period of study (sequences… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Rivaroxaban film-coated tablet 10 mg and Xarelto® film-coated tablet 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteRussia
- Study dates
- 13 Feb 2021to 1 Mar 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy caucasian men aged between 18 to 45 years;
- verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods, physical examination and anamnestic examination;
- body mass index 18.5-30 kg/m²;
- the results of an X-ray or fluorographic examination of the chest organs within the normal range (the results of an examination carried out within 12 months before the start of the study may be provided);
- consent to use a double barrier method of contraception (condom + spermicide) or complete sexual abstinence, as well as consent not to take part in sperm donation from the moment of taking the drug in the first period, during the entire study and within 14 days after taking the drug in the second period research;
- subjects are able to understand the requirements of the study, to sign a written informed consent, and also to accept all the restrictions imposed during the course of the study, and to agree to return for the required investigations.
Who cannot join
- burdened allergic history, hypersensitivity to rivaroxaban or excipients that are part of any of the investigational drugs, or intolerance to these components;
- clinically significant pathologies of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys and blood;
- other diseases that, in the opinion of the researcher, may affect the absorption, distribution, metabolism or excretion of both drugs, or increase the risk of negative consequences for the volunteer;
- a history of brain or spinal cord injury, recent surgery on the brain, spinal cord or eyes;
- history of internal bleeding of any genesis;
- a history of coagulation disorders (eg, von Willebrand disease, hemophilia);
Show all 33Show fewer
- hereditary intolerance to lactose or galactose (for example, congenital lactase deficiency or glucose-galactose malabsorption), since the composition of the tested and reference drugs includes lactose monohydrate;
- the presence of mental disorders, including a history;
- seizures, epilepsy and any other neurological disorders in history;
- surgical interventions on the gastrointestinal tract, with the exception of appendectomy;
- acute infectious diseases that ended less than 4 weeks before taking the drug in the first period;
- dehydration due to diarrhea, vomiting or other reason within the last 24 hours before taking the drug in the first period of the study. Moreover, if vomiting or diarrhea was a manifestation of an infectious disease, then participation in the study is possible only 4 weeks after the last symptom.
- Clinically significant abnormalities on the ECG, the level of systolic blood pressure (SBP) measured in the sitting position at the time of screening <100 mm Hg or ≥ 130 mm Hg and / or diastolic blood pressure (DBP) <60 mm Hg or ≥ 85 mm Hg;
- Heart rate less than 60 beats/min or more than 90 beats/min at the time of screening, respiratory rate less than 12 or more than 18 per minute at the time of screening, body temperature below 36.0 ° C or above 37.0 ° C at the time of screening;
- use of any prescription and ATC drugs:
- including herbs and food additives, vitamins that can have a significant effect on the PK of rivaroxaban or data on the effect of which on the pharmacokinetics of rivaroxaban are unknown, as well as question the characterization of the volunteer as healthy, less than 14 days before taking the drug in the first period;
- including the use of drugs that are inducers or inhibitors of isoenzymes CYP3A4, CYP2J2 (HIV protease inhibitors, antifungal drugs of the azole group, clarithromycin, erythromycin, phenytoin, carbamazepine, phenobarbital, St. John's wort preparations, etc.), less than 30 days before taking the drug in the first period;
- donation of plasma or blood (450 ml or more) less than 2 months (60 days) before taking the drug in the first period;
- consumption of caffeine and xanthine-containing drinks and products (tea, coffee, chocolate, cola, etc.), products containing poppy seeds, less than 48 hours before taking the drug in the first period;
- consumption of alcohol and alcohol-containing foods and beverages less than 48 hours before taking the drug in the first period;
- use of citrus fruits (including grapefruit and grapefruit juice) and cranberries (including juices, fruit drinks, etc.) less than 7 days before taking the drug in the first period;
- intake of more than 10 units alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml dry wine or 50 ml of spirits) or history of alcoholism, drug addiction, drug abuse;
- intense physical activity less than 24 hours before taking the drug in the first period;
- smoking more than 10 cigarettes per day, including less than 24 hours before taking the drug in each period and during each study period;
- participation in other clinical trials of drugs less than 3 months before taking the drug in the first period;
- test positive for syphilis, hepatitis B, hepatitis C or HIV at the time of screening;
- positive test for alcohol in exhaled air;
- positive urinalysis for the content of narcotic and potent substances during screening (opiates, morphine, barbiturates, benzodiazepines, cannabinoids/marijuana);
- the value of standard laboratory and instrumental parameters that go beyond the reference values;
- lack of intention of volunteers to comply with the Protocol requirements throughout the course of the study and/or lack, in the opinion of the Investigator, of the volunteers' ability to understand and evaluate the information on this study as part of the informed consent form signing process, in particular regarding the expected risks and possible discomfort;
- tattooing and piercing within 30 days prior to first drug administration;
- difficulty swallowing tablets;
- difficulty with taking blood (for example, difficult access to the veins).
Trial locations and contacts
1 site in 1 country.
Russia1 site
Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Yaroslavl"
Yaroslavl, 150047
Alexander Khokhlov, 81079109756777
About this study
Official title: Randomized Crossover 2-Period Single-dose BE Study of Rivaroxaban Film-coated Tablets 10mg (Pharmtechnology LLC, Republic of Belarus) and Xarelto® Film-coated Tablets 10mg (Bayer AG, Germany) in Healthy Male Volunteers in Fasting Conditions
This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test (Rivaroxaban, 10 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
- Conditions
- Bioequivalence
- Being tested
- Rivaroxaban film-coated tablet 10 mg, Xarelto® film-coated tablet 10 mg
- Keywords
- Rivaroxaban, Bioequivalence, Xarelto
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban film-coated tablet 10 mgDrug
Also called The test product
Rivaroxaban is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 10 mg of rivaroxaban.
Xarelto® film-coated tablet 10 mgDrug
Also called The reference product
Xarelto® is manufactured by Bayer AG, Germany. Each tablet contains 10 mg of rivaroxaban.
| Study group | Role | What they receive |
|---|---|---|
| Sequence TR | Other | 17 subjects assigned to the sequence TR will receive a single 10 mg dose of the test product Rivaroxaban (1 x 10 mg tablet), marked as T in the sequence, in Period 1 and a single 10 mg dose of the reference product Xarelto® (1 x 10 mg tablet), marked as R in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, after overnight fasting. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Rivaroxaban film-coated tablet 10 mg; Drug: Xarelto® film-coated tablet 10 mg |
| Sequence RT | Other | 17 subjects assigned to the sequence RT will receive a single 10 mg dose of the reference product Xarelto® (1 x 10 mg tablet), marked as R in the sequence, in Period 1 and a single 10 mg dose of the test product Rivaroxaban (1 x 10 mg tablet), marked as T in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, after overnight fasting. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Rivaroxaban film-coated tablet 10 mg; Drug: Xarelto® film-coated tablet 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of rivaroxaban in plasma after administration of the test and the reference products.
Maximum observed concentration in plasma.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
AUC0-t of rivaroxaban in plasma after administration of the test and the reference.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration using the linear trapezoidal method
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
Secondary outcomes (5)
Tmax of rivaroxaban in plasma after administration of the test and the reference products.
Time of maximum observed concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
AUC0-INF of rivaroxaban in plasma after administration of the test and the reference products.
Area under the concentration time curve extrapolated to infinity, calculated as AUC0-t + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant).
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
Residual area of rivaroxaban in plasma after administration of the test and the reference products.
Extrapolated area (AUCresid%=100%*(AUC0-INF - AUC0-t)/AUC0-INF).
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
λZ of rivaroxaban in plasma after administration of the test and the reference products.
Apparent elimination rate constant.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
Terminal elimination half-life (T1/2) of rivaroxaban in plasma after administration of the test and the reference products.
Terminal elimination half-life, calculated as ln(2)/λZ.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start13 Feb 2021 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Responsible party
- Sponsor
- Investigators
- Alexander Khokhlov, Principal investigator, ClinPharmInvest, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753489
- Sponsor's protocol ID
- RVRX_10-2020-CPD-FRMT
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover 2-Period Single-dose BE Study of Rivaroxaban Film-coated Tablets 10mg (Pharmtechnology LLC, Republic of Belarus) and Xarelto® Film-coated Tablets 10mg (Bayer AG, Germany) in Healthy Male Volunteers in Fasting Conditions
- ClinicalTrials.gov ID
- NCT04753489
- Acronym / sponsor ID
- RVRX_10-2020-CPD-FRMT
- Conditions
- Bioequivalence
- Keywords
- Rivaroxaban, Bioequivalence, Xarelto
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Study start
- 13 Feb 2021 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 15 Feb 2021 (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.
This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test (Rivaroxaban, 10 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence TR | Other | Drug: Rivaroxaban film-coated tablet 10 mg, Drug: Xarelto® film-coated tablet 10 mg17 subjects assigned to the sequence TR will receive a single 10 mg dose of the test product Rivaroxaban (1 x 10 mg tablet), marked as T in the sequence, in Period 1 and a single 10 mg dose of the reference product Xarelto® (1 x 10 mg tablet), marked as R in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, after overnight fasting. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence RT | Other | Drug: Rivaroxaban film-coated tablet 10 mg, Drug: Xarelto® film-coated tablet 10 mg17 subjects assigned to the sequence RT will receive a single 10 mg dose of the reference product Xarelto® (1 x 10 mg tablet), marked as R in the sequence, in Period 1 and a single 10 mg dose of the test product Rivaroxaban (1 x 10 mg tablet), marked as T in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, after overnight fasting. The tablet must be swallowed whole and must not be chewed or broken. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy caucasian men aged between 18 to 45 years;
- verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods, physical examination and anamnestic examination;
- body mass index 18.5-30 kg/m²;
- the results of an X-ray or fluorographic examination of the chest organs within the normal range (the results of an examination carried out within 12 months before the start of the study may be provided);
- consent to use a double barrier method of contraception (condom + spermicide) or complete sexual abstinence, as well as consent not to take part in sperm donation from the moment of taking the drug in the first period, during the entire study and within 14 days after taking the drug in the second period research;
Key exclusion criteria (33 listed)
- burdened allergic history, hypersensitivity to rivaroxaban or excipients that are part of any of the investigational drugs, or intolerance to these components;
- clinically significant pathologies of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys and blood;
- other diseases that, in the opinion of the researcher, may affect the absorption, distribution, metabolism or excretion of both drugs, or increase the risk of negative consequences for the volunteer;
- a history of brain or spinal cord injury, recent surgery on the brain, spinal cord or eyes;
- history of internal bleeding of any genesis;
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 |
|---|---|---|
| Rivaroxaban film-coated tablet 10 mgAlso: The test productRivaroxaban is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 10 mg of rivaroxaban. | Drug | Sequence RT, Sequence TR |
| Xarelto® film-coated tablet 10 mgAlso: The reference productXarelto® is manufactured by Bayer AG, Germany. Each tablet contains 10 mg of rivaroxaban. | Drug | Sequence RT, Sequence TR |
Primary outcome
Cmax of rivaroxaban in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
Maximum observed concentration in plasma.
AUC0-t of rivaroxaban in plasma after administration of the test and the reference.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration using the linear trapezoidal method
5 secondary outcomes
Tmax of rivaroxaban in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
AUC0-INF of rivaroxaban in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
Residual area of rivaroxaban in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
λZ of rivaroxaban in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
Terminal elimination half-life (T1/2) of rivaroxaban in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
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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.
Alexander Khokhlov principal investigator
ClinPharmInvest, LLC
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 Rivaroxaban film-coated tablet 10 mg and Xarelto® film-coated tablet 10 mg in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Russia.
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 33 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: status not confirmed, as of the sponsor's last update on 15 Feb 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronika Kumpel (80173094418, specialist.fs@ft.by), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of rivaroxaban in plasma after administration of the test and the reference products. (time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00. 48.00 hours after each drug administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2021.