Healthy SubjectsPhase 1NCT06248801
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets
A Phase 1 study testing Vildagliptin and Metformin-Test product and Vildagliptin and Metformin-Reference product in people with Healthy Subjects, run by Bio-innova Co., Ltd.
Trial summary
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Vildagliptin and Metformin-Test product and Vildagliptin and Metformin-Reference product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2024to 15 Oct 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 - 55 years, Subject must meet age requirements at the time of signing the initial informed consent and the initial study medication administration.
- Sex: Males and/or non-pregnant, non-lactating females.
- Women of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) pregnancy test performed on screening day and prior to the initial dose of each period of study medication.
- Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- postmenopausal with spontaneous amenorrhea for at least one (1) year
- bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
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- total hysterectomy and an absence of bleeding for at least 3 months.
- Weight: Each subject is required to have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 18.5 kg/m2. All weight values are to be reported according to the scale's precision. The subject's height is to be reported in centimeters to the nearest tenth. Each subject's BMI is to be calculated using the reported weight in kilograms and height in centimeters and it is to be reported to the nearest tenth (26.3 kg/m2).
- Smoking Status: Moderate smokers (up to 10 cigarettes or equivalent per day refer to Appendix VII: Nicotine Equivalence Estimates) are permitted.
- Documentation of smoking status is to be via the questionnaire in Appendix VI, with results included in the study database (if applicable), and Subject's CRF.
- Adequate venous access in both arms for the collection of a number of blood samples during the study.
- Able to understand and sign the written Informed Consent Form.
- Utilization of illiterate subjects is permitted when performed according to GCP, as well as regulations/guidances for the region of submission and country of conductance.
- Willing to follow the protocol requirements and comply with protocol restrictions and allow investigators to draw approximately 7 mL of blood for monitoring subjects' safety after the completion of the study.
- Willing to follow precautions during driving and operating machines
- All subjects should be judged by the Principal Investigator or Medical Sub-Investigator as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication which will include:
- a normal or non-clinically significant physical examination, including vital signs (blood pressure, pulse rate, respiratory rate and forehead-surface temperature)
- within normal limits or non-clinically significant laboratory evaluation results for the following tests (unless otherwise noted in the Exclusion Criteria):
- Serum Chemistries Alkaline Phosphatase Albumin Creatinine AST Blood sugar (by DTX) Total Protein Total Bilirubin ALT Direct Bilirubin BUN
- Hematology Platelet Count White Blood Cell Count Hemoglobin Hematocrit Red Blood Cell Count Neutrophils Lymphocytes Monocytes Eosinophils Basophils MCV, MCH, MCHC
- Additional tests may be performed, if necessary, based on standard lab panels utilized by the clinical site.
- Normal or non-clinically significant 12-lead EKG
- Negative Hepatitis B antigen test
- Negative Hepatitis C antibody test
- Negative HIV test
- Negative urine drug screen including at a minimum Metamphetamines, benzodiazepines, cocaine, opioids and Marijuana (THC),
- if tobacco/nicotine use is suspected, a urine cotinine test may be performed at the discretion of the Principal Investigator or responsible physician and if performed, must be negative,
- if warranted, other tests and/or examinations may be performed at the discretion of the Principal Investigator or responsible physician.
Who cannot join
- Institutionalized subjects.
- Social Habits:
- Consumption of any alcoholic beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
- Consumption of any caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
- Consumption of seville oranges grapefruit, grapefruit-like, or grapefruit containing products within 48 hours prior to the initial administration of the study medication and until the completion of each period of the study.
- Any recent, significant change in dietary or abnormal diet within 48.0 hours prior to dosing.
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- History of drug and/or alcohol abuse within one year of start of study.
- Use of any nicotine containing product within the 7 days of the initial administration of study medication until the completion of the study.
- Medications
- Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial administration of study medication.
- A depot injection or implant of any drug within 3 months prior to initial administration of study medication.
- Use of any medication, vitamin, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity within 14 days prior to the initial administration of study medication.
- Diseases:
- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator.
- History of tuberculosis.
- History of difficulties in swallowing, or any gastrointestinal disease (i.e. cholecystectomy) or previous GI surgery other than appendectomy which could affect drug absorption. History of gastrointestinal obstruction, particularly paralytic ileus.
- Acute illness at the time of either the pre-study medical evaluation or dosing period I.
- Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study.
- Intolerance to venipuncture.
- Donation or loss of blood or plasma within 90 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to Vildagliptin, Metformin, other related products, or any inactive ingredients.
- Subjects who have received an investigational drug within 90 days prior to the initial dose of study medication.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the subject's participation in this study.
- Subject with B.P. is Systolic B.P < 90, ≥140 mm/Hg, Diastolic B.P < 60, ≥90 mm/Hg or pulse rate > 100 beats per minute.
- Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
- Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
- Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
- Participation in any clinical study within the past 3 months before the study. (* Depend on decision of principal investigator, medical sub-investigator and/or clinical investiagtor)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Bioequivalence Study of Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets in Healthy Thai Adult Volunteers Under Fed Condition.
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 14 days washout period between the doses.
Read the detailed description
This protocol describes an open labelled, single-dose, randomized, two-period, two-treatment, two-sequence crossover study to investigate the bioequivalence of two formulations of Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India to GALVUS MET (50mg/1000 mg) tablets manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany.
Single-dose fed pharmacokinetics will be characterized in 48 healthy, adult volunteers, for a total of 48 healthy adult subjects.
Approximately eight milliliter (1 × 8 mL) blood samples will be collected in K3 EDTA tubes at pre-dose and the following times after dosing: at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours.
The collected blood samples will be transferred into centrifugation room at controlled temperature (2-8°C) and start centrifuged at 4±2°C within 2 hours after blood sample collection. Up to four (4) aliquots of plasma will be added in four pre-labeled cryovials for approximately 1 mL per each cryovial. Two aliquots for analyze vildagliptin and two aliquotes for analyze metformin. Cryovials containing plasma sample will be transferred to deep freezer in controlled temperature (2-8 °C) and will be stored at -70±10 °C.
For the determination of the pharmacokinetic disposition of the formulations, there will be a total of 48 blood samples involving a total of 385 mL (including 10 mL for screening and 7 mL for post-study safety monitoring) of blood collected for pharmacokinetic analysis from each subject who provid their complete all blood collections in the study. There will be at least 7 days between dosing times for the treatment periods.
The bioequivalence of Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India to GALVUS MET (50mg/1000 mg) tablets manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of Vildagliptin and Metformin.
- Conditions
- Healthy Subjects
- Being tested
- Vildagliptin and Metformin-Test product, Vildagliptin and Metformin-Reference product
- Keywords
- Bioequivalence Vildagliptin and Metformin tablets 50/1000 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vildagliptin and Metformin-Test productDrug
Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India
Vildagliptin and Metformin-Reference productDrug
Vildagliptin and Metformin tablets 50/1000 mg manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1-Vildagliptin and Metformin test product and then reference product | Experimental | Participants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Vildagliptin and Metformin tablets 50/1000 mg test product, treatment 2= Vildagliptin and Metformin tablets 50/1000 mg reference product. Receives: Drug: Vildagliptin and Metformin-Test product |
| Sequence 1-Vildagliptin and Metformin reference product and then test product | Experimental | Participants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Vildagliptin and Metformin tablets 50/1000 mg test product, treatment 2= Vildagliptin and Metformin tablets 50/1000 mg reference product. Receives: Drug: Vildagliptin and Metformin-Reference product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)
pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
Measured: Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
Maximal measured plasma concentration (Cmax)
pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
Measured: Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
Secondary outcomes (1)
Number of subjects with adverse events
An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Approximately the day 14 after the last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start5 Sep 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-innova Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sasitorn Kittivoravitkul, Bio-innova Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248801
- Sponsor's protocol ID
- VME-005-22
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Company Policy
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets in Healthy Thai Adult Volunteers Under Fed Condition.
- ClinicalTrials.gov ID
- NCT06248801
- Acronym / sponsor ID
- VME-005-22
- Conditions
- Healthy Subjects
- Keywords
- Bioequivalence Vildagliptin and Metformin tablets 50/1000 mg
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bio-innova Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 8 Feb 2024 (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.
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 14 days washout period between the doses.
Detailed description
This protocol describes an open labelled, single-dose, randomized, two-period, two-treatment, two-sequence crossover study to investigate the bioequivalence of two formulations of Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India to GALVUS MET (50mg/1000 mg) tablets manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany.
Single-dose fed pharmacokinetics will be characterized in 48 healthy, adult volunteers, for a total of 48 healthy adult subjects.
Approximately eight milliliter (1 × 8 mL) blood samples will be collected in K3 EDTA tubes at pre-dose and the following times after dosing: at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours.
The collected blood samples will be transferred into centrifugation room at controlled temperature (2-8°C) and start centrifuged at 4±2°C within 2 hours after blood sample collection. Up to four (4) aliquots of plasma will be added in four pre-labeled cryovials for approximately 1 mL per each cryovial. Two aliquots for analyze vildagliptin and two aliquotes for analyze metformin. Cryovials containing plasma sample will be transferred to deep freezer in controlled temperature (2-8 °C) and will be stored at -70±10 °C.
For the determination of the pharmacokinetic disposition of the formulations, there will be a total of 48 blood samples involving a total of 385 mL (including 10 mL for screening and 7 mL for post-study safety monitoring) of blood collected for pharmacokinetic analysis from each subject who provid their complete all blood collections in the study. There will be at least 7 days between dosing times for the treatment periods.
The bioequivalence of Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India to GALVUS MET (50mg/1000 mg) tablets manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of Vildagliptin and Metformin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1-Vildagliptin and Metformin test product and then reference product | Experimental | Drug: Vildagliptin and Metformin-Test productParticipants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Vildagliptin and Metformin tablets 50/1000 mg test product, treatment 2= Vildagliptin and Metformin tablets 50/1000 mg reference product. |
| Sequence 1-Vildagliptin and Metformin reference product and then test product | Experimental | Drug: Vildagliptin and Metformin-Reference productParticipants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Vildagliptin and Metformin tablets 50/1000 mg test product, treatment 2= Vildagliptin and Metformin tablets 50/1000 mg reference product. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- Age: 18 - 55 years, Subject must meet age requirements at the time of signing the initial informed consent and the initial study medication administration.
- Sex: Males and/or non-pregnant, non-lactating females.
- Weight: Each subject is required to have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 18.5 kg/m2. All weight values are to be reported according to the scale's precision. The subject's height is to be reported in centimeters to the nearest tenth. Each subject's BMI is to be calculated using the reported weight in kilograms and height in centimeters and it is to be reported to the nearest tenth (26.3 kg/m2).
- Smoking Status: Moderate smokers (up to 10 cigarettes or equivalent per day refer to Appendix VII: Nicotine Equivalence Estimates) are permitted.
- Adequate venous access in both arms for the collection of a number of blood samples during the study.
Key exclusion criteria (28 listed)
- Institutionalized subjects.
- Social Habits:
- Medications
- Diseases:
- Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study.
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 |
|---|---|---|
| Vildagliptin and Metformin-Test productVildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India | Drug | Sequence 1-Vildagliptin and Metformin test product and then reference product |
| Vildagliptin and Metformin-Reference productVildagliptin and Metformin tablets 50/1000 mg manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany. | Drug | Sequence 1-Vildagliptin and Metformin reference product and then test product |
Primary outcome
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)
Time frame: Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
Maximal measured plasma concentration (Cmax)
Time frame: Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
1 secondary outcome
Number of subjects with adverse events
Time frame: Approximately the day 14 after the last visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No. Company Policy
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vildagliptin and Metformin-Test product and Vildagliptin and Metformin-Reference product in people with Healthy Subjects, run by Bio-innova Co., Ltd.
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 28 inclusion and 28 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Sasitorn Kittivoravitkul, Ph.D. (022549008, sasitorn_k@bio-innova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) (time frame: Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.). 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 8 Feb 2024.