Drug InteractionKF2022#4NCT06566794
KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism
A study testing Caffeine Tablet, Bupropion Hydrochloride Capsels and Repaglinide Capsels in people with Drug Interaction, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Carvedilol is a non-selective beta-blocker in common clinical use, used to treat hypertension, heart failure, and angina pectoris symptoms associated with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Caffeine Tablet, Bupropion Hydrochloride Capsels and Repaglinide Capsels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- 22 Aug 2024to 10 Jan 2025
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Age 18-40
- Healthy
- Systolic blood pressure ≥110 mmHg
- Heart rate ≥ 55/min
- Normal ECG
- Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatine kinase, creatinine, plasma glucose concentration, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
Who cannot join
- Significant disease
- Previous or current gastrointestinal bleeding, ulcer or perforation
- Findings of a medical examination and laboratory tests, which require a more detailed examination of the state of health
- Smoking
- Hormonal birth control or other regular medication
- Pregnancy (current or planned) or nursing
Show all 12Show fewer
- Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study
- Donation of blood within three months prior to the entry into this study
- Significant overweight / small or hard-to-find veins
- BMI < 18.5 kg/m2
- Insufficient Finnish language skills
- Hypersensitivity or contraindication to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KF2022#4-tutkimus:Beetasalpaajan ja tulehduskipulääkkeen Vaikutus CYP-entsyymivälitteiseen lääkeainemetaboliaan
Carvedilol is a non-selective beta-blocker in common clinical use, used to treat hypertension, heart failure, and angina pectoris symptoms associated with coronary artery disease. Diclofenac is a non-selective anti-inflammatory drug in general use, which is used to treat rheumatic diseases, osteoarthritis, musculoskeletal pain conditions, menstrual pains and migraines, among others. In our recent experiments involving liver cell enzymes, both carvedilol and diclofenac were found to inhibit several cytochrome P450 (CYP) enzymes central to drug metabolism, potentially leading to adverse drug interactions with other drugs metabolized by the same enzyme. The purpose of this study is to investigate the effects of the use of carvedilol and diclofenac on the activity of key CYP enzymes in drug metabolism in healthy volunteers using a low-dose model drug combination covering seven CYP enzymes.
In an open three-phase, randomized, crossover study with 12 healthy volunteers, the subjects will receive a drug combination of caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam and simvastatin and as a premedication either placebo, carvedilol or diclofenac. Blood samples will be collected and carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam and simvastatin pharmacokinetics will be monitored up to 23 hours post dose.
- Conditions
- Drug Interaction
- Being tested
- Caffeine Tablet, Bupropion Hydrochloride Capsels, Repaglinide Capsels, Flurbiprofen Capsels, Omeprazole 10 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine TabletDrug
Also called YA Kofeiinitabletti 100 mg, Yliopiston apteekki
0,5 x 100 mg tablet (50 mg caffeine).
Bupropion Hydrochloride CapselsDrug
Also called Bupropion hydrochloride 20 mg caps, HUS Apteekki
1 x 20 mg tablet.
Repaglinide CapselsDrug
Also called Repaglinide 0.05 mg caps, HUS Apteekki
1 x 0,05 mg tablet.
Flurbiprofen CapselsDrug
Also called Flurbiprofen 10 mg caps, HUS Apteekki
1 x 10 mg tablet.
Omeprazole 10 MGDrug
Also called Losec Mups 10 mg enterotablet, AstraZeneca
1 x 10 mg tablet.
Dextromethorphan Oral SolutionDrug
Also called Rometor Ratiopharm 2 mg/ml oral solution, Ratiopharm
5,0 ml of 2 mg/ml oral solution (10 mg dextromethorphan).
Midazolam oral solutionDrug
Also called Midazolam-Ratiopharm 2 mg/ml oral solution, Ratiopharm
0,5 ml of 2 mg/ml oral solution (1,0 mg midazolam).
Simvastatin tabletsDrug
Also called Simvastatin Krka 10 mg tablet, KRKA
1 x 10 mg tablet.
PlaceboDrug
Also called Placebo, 9 mm tablet, Yliopiston apteekki
2 x placebo tablets in the Placebo Phase/Arm
CarvedilolDrug
Also called Carvedilol STADA 25 mg tablet, STADA Arzneimittel AG
2 x 25 mg tablets
DiclofenacDrug
Also called Voltaren Rapid 50 mg, Novartis Finland Oy
1 x 50 mg tablet (three times daily for three days)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablets (2 x Placebo) and 150 ml water at 8.00 a.m. on the study day.
Study drug doses (caffeine 50 mg, bupropion 20 mg, repaglinide 0,05 mg, flurbiprofen 10 mg, omeprazole 10 mg, dextromethorphan 10 mg, midazolam 1,0 mg, simvastatin 10 mg) and 250 ml water at 9:00 a.m. Receives: Drug: Caffeine Tablet; Drug: Bupropion Hydrochloride Capsels; Drug: Repaglinide Capsels; Drug: Flurbiprofen Capsels; Drug: Omeprazole 10 MG; Drug: Dextromethorphan Oral Solution; Drug: Midazolam oral solution; Drug: Simvastatin tablets; Drug: Placebo |
| Carvedilol | Active comparator | Carvedilol tablets (2 x Carvedilol STADA 25 mg) and 150 ml water at 8.00 a.m. on the study day.
Study drug doses (caffeine 50 mg, bupropion 20 mg, repaglinide 0,05 mg, flurbiprofen 10 mg, omeprazole 10 mg, dextromethorphan 10 mg, midazolam 1,0 mg, simvastatin 10 mg) and 250 ml water at 9:00 a.m. Receives: Drug: Caffeine Tablet; Drug: Bupropion Hydrochloride Capsels; Drug: Repaglinide Capsels; Drug: Flurbiprofen Capsels; Drug: Omeprazole 10 MG; Drug: Dextromethorphan Oral Solution; Drug: Midazolam oral solution; Drug: Simvastatin tablets; Drug: Carvedilol |
| Diclofenac | Active comparator | Diclofenac tablet (1 x Voltaren Rapid 50 mg) three times a day around 8.00 a.m., 3.00 p.m. and 9.00 p.m. for three days.
Diclofenac tablet (1 x Voltaren Rapid 50 mg) and 150 ml water at 8.00 a.m., 3.00 p.m. and 9.00 p.m. on the study day (3rd day of diclofenac treatment).
Study drug doses (caffeine 50 mg, bupropion 20 mg, repaglinide 0,05 mg, flurbiprofen 10 mg, omeprazole 10 mg, dextromethorphan 10 mg, midazolam 1,0 mg, simvastatin 10 mg) and 250 ml water at 9:00 a.m. Receives: Drug: Caffeine Tablet; Drug: Bupropion Hydrochloride Capsels; Drug: Repaglinide Capsels; Drug: Flurbiprofen Capsels; Drug: Omeprazole 10 MG; Drug: Dextromethorphan Oral Solution; Drug: Midazolam oral solution; Drug: Simvastatin tablets; Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration - time curve of carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam and simvastatin
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Secondary outcomes (5)
Peak plasma concentration for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Half-life for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Time to peak plasma concentration for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Fractional areas under concentration-time curve (AUC) for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Areas under concentration-time curve (AUC) for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start22 Aug 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Janne Backman, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566794
- Sponsor's protocol ID
- KF2022#4
- Other IDs
- 2023-000002-25, 2023
- Acronym
- KF2022#4
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KF2022#4-tutkimus:Beetasalpaajan ja tulehduskipulääkkeen Vaikutus CYP-entsyymivälitteiseen lääkeainemetaboliaan
- ClinicalTrials.gov ID
- NCT06566794
- Acronym / sponsor ID
- KF2022#4 / KF2022#4
- Conditions
- Drug Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 22 Aug 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.
Carvedilol is a non-selective beta-blocker in common clinical use, used to treat hypertension, heart failure, and angina pectoris symptoms associated with coronary artery disease. Diclofenac is a non-selective anti-inflammatory drug in general use, which is used to treat rheumatic diseases, osteoarthritis, musculoskeletal pain conditions, menstrual pains and migraines, among others. In our recent experiments involving liver cell enzymes, both carvedilol and diclofenac were found to inhibit several cytochrome P450 (CYP) enzymes central to drug metabolism, potentially leading to adverse drug interactions with other drugs metabolized by the same enzyme. The purpose of this study is to investigate the effects of the use of carvedilol and diclofenac on the activity of key CYP enzymes in drug metabolism in healthy volunteers using a low-dose model drug combination covering seven CYP enzymes.
In an open three-phase, randomized, crossover study with 12 healthy volunteers, the subjects will receive a drug combination of caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam and simvastatin and as a premedication either placebo, carvedilol or diclofenac. Blood samples will be collected and carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam and simvastatin pharmacokinetics will be monitored up to 23 hours post dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Caffeine Tablet, Drug: Bupropion Hydrochloride Capsels, Drug: Repaglinide Capsels, Drug: Flurbiprofen Capsels, Drug: Omeprazole 10 MG, Drug: Dextromethorphan Oral Solution, Drug: Midazolam oral solution, Drug: Simvastatin tablets, Drug: PlaceboPlacebo tablets (2 x Placebo) and 150 ml water at 8.00 a.m. on the study day. Study drug doses (caffeine 50 mg, bupropion 20 mg, repaglinide 0,05 mg, flurbiprofen 10 mg, omeprazole 10 mg, dextromethorphan 10 mg, midazolam 1,0 mg, simvastatin 10 mg) and 250 ml water at 9:00 a.m. |
| Carvedilol | Active comparator | Drug: Caffeine Tablet, Drug: Bupropion Hydrochloride Capsels, Drug: Repaglinide Capsels, Drug: Flurbiprofen Capsels, Drug: Omeprazole 10 MG, Drug: Dextromethorphan Oral Solution, Drug: Midazolam oral solution, Drug: Simvastatin tablets, Drug: CarvedilolCarvedilol tablets (2 x Carvedilol STADA 25 mg) and 150 ml water at 8.00 a.m. on the study day. Study drug doses (caffeine 50 mg, bupropion 20 mg, repaglinide 0,05 mg, flurbiprofen 10 mg, omeprazole 10 mg, dextromethorphan 10 mg, midazolam 1,0 mg, simvastatin 10 mg) and 250 ml water at 9:00 a.m. |
| Diclofenac | Active comparator | Drug: Caffeine Tablet, Drug: Bupropion Hydrochloride Capsels, Drug: Repaglinide Capsels, Drug: Flurbiprofen Capsels, Drug: Omeprazole 10 MG, Drug: Dextromethorphan Oral Solution, Drug: Midazolam oral solution, Drug: Simvastatin tablets, Drug: DiclofenacDiclofenac tablet (1 x Voltaren Rapid 50 mg) three times a day around 8.00 a.m., 3.00 p.m. and 9.00 p.m. for three days. Diclofenac tablet (1 x Voltaren Rapid 50 mg) and 150 ml water at 8.00 a.m., 3.00 p.m. and 9.00 p.m. on the study day (3rd day of diclofenac treatment). Study drug doses (caffeine 50 mg, bupropion 20 mg, repaglinide 0,05 mg, flurbiprofen 10 mg, omeprazole 10 mg, dextromethorphan 10 mg, midazolam 1,0 mg, simvastatin 10 mg) and 250 ml water at 9:00 a.m. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent
- Age 18-40
- Healthy
- Systolic blood pressure ≥110 mmHg
- Heart rate ≥ 55/min
Key exclusion criteria (12 listed)
- Significant disease
- Previous or current gastrointestinal bleeding, ulcer or perforation
- Findings of a medical examination and laboratory tests, which require a more detailed examination of the state of health
- Smoking
- Hormonal birth control or other regular medication
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 |
|---|---|---|
| Caffeine TabletAlso: YA Kofeiinitabletti 100 mg, Yliopiston apteekki0,5 x 100 mg tablet (50 mg caffeine). | Drug | Carvedilol, Diclofenac, Placebo |
| Bupropion Hydrochloride CapselsAlso: Bupropion hydrochloride 20 mg caps, HUS Apteekki1 x 20 mg tablet. | Drug | Carvedilol, Diclofenac, Placebo |
| Repaglinide CapselsAlso: Repaglinide 0.05 mg caps, HUS Apteekki1 x 0,05 mg tablet. | Drug | Carvedilol, Diclofenac, Placebo |
| Flurbiprofen CapselsAlso: Flurbiprofen 10 mg caps, HUS Apteekki1 x 10 mg tablet. | Drug | Carvedilol, Diclofenac, Placebo |
| Omeprazole 10 MGAlso: Losec Mups 10 mg enterotablet, AstraZeneca1 x 10 mg tablet. | Drug | Carvedilol, Diclofenac, Placebo |
| Dextromethorphan Oral SolutionAlso: Rometor Ratiopharm 2 mg/ml oral solution, Ratiopharm5,0 ml of 2 mg/ml oral solution (10 mg dextromethorphan). | Drug | Carvedilol, Diclofenac, Placebo |
| Midazolam oral solutionAlso: Midazolam-Ratiopharm 2 mg/ml oral solution, Ratiopharm0,5 ml of 2 mg/ml oral solution (1,0 mg midazolam). | Drug | Carvedilol, Diclofenac, Placebo |
| Simvastatin tabletsAlso: Simvastatin Krka 10 mg tablet, KRKA1 x 10 mg tablet. | Drug | Carvedilol, Diclofenac, Placebo |
| PlaceboAlso: Placebo, 9 mm tablet, Yliopiston apteekki2 x placebo tablets in the Placebo Phase/Arm | Drug | Placebo |
| CarvedilolAlso: Carvedilol STADA 25 mg tablet, STADA Arzneimittel AG2 x 25 mg tablets | Drug | Carvedilol |
| DiclofenacAlso: Voltaren Rapid 50 mg, Novartis Finland Oy1 x 50 mg tablet (three times daily for three days) | Drug | Diclofenac |
Primary outcome
Area under the plasma concentration - time curve of carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam and simvastatin
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
5 secondary outcomes
Peak plasma concentration for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Half-life for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Time to peak plasma concentration for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Fractional areas under concentration-time curve (AUC) for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
Areas under concentration-time curve (AUC) for carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam, simvastatin and their metabolites.
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.
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 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Drug Interaction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
RecruitingObservational study
Pediatric Research in the Outpatient Setting CoHort
Parental Stress, Communication Disorder, Childhood
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?
A study testing Caffeine Tablet, Bupropion Hydrochloride Capsels and Repaglinide Capsels in people with Drug Interaction, run by Helsinki University Central Hospital at 1 site in Finland.
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 7 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 6 Mar 2026. 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 Finland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Area under the plasma concentration - time curve of carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam and simvastatin (time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 23 hours after administration the drugs.). 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 6 Mar 2026.