HealthyPhase 4NCT05380245
Drug-Drug Interaction Study of Voriconazole With Clarithromycin.
A Phase 4 study testing Voriconazole 200 mg x 2 Tablets and Clarithromycin 500 mg x 1Tablets in people with Healthy, run by Abdul Wali Khan University Mardan at 1 site in Pakistan.
Trial summary
The current study evaluated the Pharmacokinetic (PK) drug-drug interaction (PK-DDI) of voriconazole with clarithromycin in healthy male volunteers. The drug interaction study was designed as a single oral dose, open-label, crossover, and randomized trial. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Voriconazole 200 mg x 2 Tablets and Clarithromycin 500 mg x 1Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2018to 30 Nov 2018
- Phase
- Phase 4
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male Pakistani volunteers in good health aged 18-35 years were enrolled as participants in this study.
- The selection was based on:
- A complete detailed medical history,
- Clinical examination,
- Voriconazole hypersensitivity test,
- Evaluation of various biochemical tests like Blood Glucose Level, Hemoglobin (Hb) Level, Serum Glutamic-Pyruvic Transaminase (SGPT) Or Alanine Amino Transferase and Aspartate (ALT and AST, respectively) Level, Urine Test, Albumin to Creatinine Ratio (ACR) Test, Glomerular Filtration Rate (GFR) Level, etc.
Who cannot join
- Those volunteers were having a history of voriconazole hypersensitivity reaction were excluded from the study.
- Deviation from normal values in the biochemical test report was excluded from the study.
- Having any pathology like chronic renal disease, and hepatic impairment was excluded from the study.
- Having any cardiovascular, gastrointestinal tract, and hematopoietic disorders were excluded from the study.
- Alcohol addicted, smokers and volunteers who cannot sign the permission consent form were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Medical Dispensary, Abdul Wali Khan University Mardan, Pakistan.
Mardan, KPK, 25000
About this study
Official title: Pharmacokinetic Drug-Drug Interaction Study of Voriconazole With Clarithromycin.
The current study evaluated the Pharmacokinetic (PK) drug-drug interaction (PK-DDI) of voriconazole with clarithromycin in healthy male volunteers. The drug interaction study was designed as a single oral dose, open-label, crossover, and randomized trial. In the first phase of the study, the principal investigator developed a high-performance-liquid chromatography (HPLC) method and validation according to standard ICH guidelines for the quantification of voriconazole in the biological matrix. During the second step, Enrolled volunteers were divided randomly into group A and group B by the "permuted block randomization" technique. Then, voriconazole either alone (2 x 200mg, tab, P/O) or in combination with clarithromycin (Voriconazole 2 x 200mg, tab + clarithromycin 500mg, tab, P/O) was administered to enrolled volunteers in two sequences. Finally, sample collection was carried out and blood samples were collected at specified time periods (i.e., 0.0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, and 24 hours) in EDTA or heparinized tubes from the enrolled human volunteers. Further processing of the sample was done for extractions and subsequent analysis with the developed analytical method.
Read the detailed description
Study Design and Ethical Approval: The drug interaction study was designed as a single oral dose, open-label, randomized, cross-over study of healthy volunteers. The ethical approval of the protocol was taken from the Advanced Studies and Research Board (ASRB) of the Pharmacy department, Abdul Wali Khan University, Mardan before initiation. This study followed the "ethical principles of the Helsinki declaration for medical research involving human subjects" and "good clinical practice guidelines". The clinical trial of this study followed the guidelines of CONSORT. Written consent was obtained from all included volunteers in the DDI study. The study was comprised of two treatment sequences with a two-week washout period
Randomization and Drug administration: Enrolled volunteers were divided randomly into Group A and Group B by the "permuted block randomization" technique. Computed the volunteer data into an excel sheet and applied a RAND* function; selected two groups (G-A and G-B) sized, finally assigned 6 participants in each study group for two (Voriz (alone) or Voriz + CLRM) intervention arms, for the execution of block randomization. A balance (1:1) was acquired across both intervention arms through this randomization technique. Treatment drugs were administered to enrolled volunteers in two sequences,
Sequence-I: In the first phase, group-A volunteers on day-1 received oral voriconazole (2 x 200mg, tab, P/O) while group-B volunteers received oral clarithromycin (500mg, tab, P/O) along with voriconazole (2 x 200mg, tab, P/O). A two-week wash-out period was allocated that started on day-2 to day-15 for avoiding the carry-over effect.
Sequence-II: On day-16, the second phase of the trial was conducted in which group-A volunteers received voriconazole (2 x 200mg, tab, P/O) along with clarithromycin (500mg, tab, P/O) while group-B volunteers received Voriz (2 x 200mg, tab, P/O) only. Voriconazole and clarithromycin were administered to the overnight fasted volunteers corresponding to the sequences. All volunteers took the medication with a glass of water (250mL). On day-1 and 16 (treatment days), standard breakfast and lunch were served two and six hours after drug administration to all volunteers, respectively.
- Conditions
- Healthy
- Being tested
- Voriconazole 200 mg x 2 Tablets, Clarithromycin 500 mg x 1Tablets
- Keywords
- Voriconazole (Voriz), Clarithromycin (CLRM), Washout period, Randomized, Pharmacokinetic drug-drug interaction (PK-DDI), Clinical significance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voriconazole 200 mg x 2 TabletsDrug
Also called Vfend®
Name of medication of Reference Formulation: Tablets Voriconazole Vfend®, 200 mg by Pfizer, Inc. (USA), (Batch No: 00005505; Mfg. date 09/2016).
Clarithromycin 500 mg x 1TabletsDrug
Also called klaricid®
Name of medication of Intervention Formulation: Tablet Klaricid, 500 mg by Abbott, Lab Pvt. Ltd. (Karachi, Pakistan), Batch No: 81573XU; Mfg. date 10/2017.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Voriconazole (alone), then Voriconazole + Clarithromycin. | Experimental | On Day-1, Group-A participants first received Voriconazole (alone) (Dose: 400mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral). After a washout period of two weeks. Then, on Day-16 they received Voriconazole (Dose: 400mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral) along with Clarithromycin (Name of medication of Intervention Formulation: Tablet Klaricid, Dose: 500mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral). Receives: Drug: Voriconazole 200 mg x 2 Tablets; Drug: Clarithromycin 500 mg x 1Tablets |
| Treatment Voriconazole + Clarithromycin, then Voriconazole (alone). | Experimental | On Day-1, Group-B participants first received Voriconazole (Dose: 400mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral) along with Clarithromycin (Name of medication of Intervention Formulation: Tablet Klaricid, Dose: 500mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral).After a washout period of two weeks. Then, on Day-16 they received Voriconazole (alone) (Dose: 400mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral). Receives: Drug: Voriconazole 200 mg x 2 Tablets; Drug: Clarithromycin 500 mg x 1Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of voriconazole
Determine the Plasma Concentration particularly the Maximum Plasma Concentration (Cmax) of voriconazole either alone or co-administration with clarithromycin.
Measured: At "Day 1" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose and At "Day 16" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose.
Area under the Plasma Concentration versus Time Curve (AUC) of voriconazole
Determine the Area under the Plasma Concentration versus Time Curve (AUC) of voriconazole either alone or co-administration with clarithromycin.
Measured: At "Day 1" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose and At "Day 16" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose.
Secondary outcomes (1)
Maximum Time to Reach (Cmax) of voriconazole (Tmax)
Tmax of voriconazole either alone or co-administration with clarithromycin.
Measured: At "Day 1" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose and At "Day 16" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Nov 2018
- Primary completion16 Nov 2018
- Study completion30 Nov 2018
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 HealthyStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A single dose, randomized, crossover, open-labeled and two sequence study with a two-week washout period, evaluated the impact of clarithromycin on the pharmacokinetics (PK) profile of voriconazole Pakistani healthy male volunteers.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdul Wali Khan University Mardan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yasar Shah, Abdul Wali Khan University Mardan
- Investigators
- Dr. Mehwish Mushtaq, MPhil, Principal investigator, Abdul Wali Khan University Mardan (AWKUM), Pakistan / Metrics Research Organization CRO, Pakistan.Dr. Yasar Shah, Ph.D., Study director, Abdul Wali Khan University Mardan (AWKUM), Pakistan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380245
- Sponsor's protocol ID
- Dir/A&R/AWKUM/2018/1408-25
- Other IDs
- AWKUM-16002974
- Status last verified
- May 2022
- First submitted
- 3 Apr 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: To keep the confidentiality of the study participants, however, data would be made available to the Ethics Committee of the institute upon requirement.
Publications
Mushtaq M, Fatima K, Ahmad A, Mohamed Ibrahim O, Faheem M, Shah Y. Pharmacokinetic interaction of voriconazole and clarithromycin in Pakistani healthy male volunteers: a single dose, randomized, crossover, open-label study. Front Pharmacol. 2023 Jun 9;14:1134803. doi: 10.3389/fphar.2023.1134803. eCollection 2023.
PubMed 37361220
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Drug-Drug Interaction Study of Voriconazole With Clarithromycin.
- ClinicalTrials.gov ID
- NCT05380245
- Acronym / sponsor ID
- Dir/A&R/AWKUM/2018/1408-25
- Conditions
- Healthy
- Keywords
- Voriconazole (Voriz), Clarithromycin (CLRM), Washout period, Randomized, Pharmacokinetic drug-drug interaction (PK-DDI), Clinical significance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Abdul Wali Khan University MardanUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 18 May 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.
The current study evaluated the Pharmacokinetic (PK) drug-drug interaction (PK-DDI) of voriconazole with clarithromycin in healthy male volunteers. The drug interaction study was designed as a single oral dose, open-label, crossover, and randomized trial. In the first phase of the study, the principal investigator developed a high-performance-liquid chromatography (HPLC) method and validation according to standard ICH guidelines for the quantification of voriconazole in the biological matrix. During the second step, Enrolled volunteers were divided randomly into group A and group B by the "permuted block randomization" technique. Then, voriconazole either alone (2 x 200mg, tab, P/O) or in combination with clarithromycin (Voriconazole 2 x 200mg, tab + clarithromycin 500mg, tab, P/O) was administered to enrolled volunteers in two sequences. Finally, sample collection was carried out and blood samples were collected at specified time periods (i.e., 0.0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, and 24 hours) in EDTA or heparinized tubes from the enrolled human volunteers. Further processing of the sample was done for extractions and subsequent analysis with the developed analytical method.
Detailed description
Study Design and Ethical Approval: The drug interaction study was designed as a single oral dose, open-label, randomized, cross-over study of healthy volunteers. The ethical approval of the protocol was taken from the Advanced Studies and Research Board (ASRB) of the Pharmacy department, Abdul Wali Khan University, Mardan before initiation. This study followed the "ethical principles of the Helsinki declaration for medical research involving human subjects" and "good clinical practice guidelines". The clinical trial of this study followed the guidelines of CONSORT. Written consent was obtained from all included volunteers in the DDI study. The study was comprised of two treatment sequences with a two-week washout period
Randomization and Drug administration: Enrolled volunteers were divided randomly into Group A and Group B by the "permuted block randomization" technique. Computed the volunteer data into an excel sheet and applied a RAND* function; selected two groups (G-A and G-B) sized, finally assigned 6 participants in each study group for two (Voriz (alone) or Voriz + CLRM) intervention arms, for the execution of block randomization. A balance (1:1) was acquired across both intervention arms through this randomization technique. Treatment drugs were administered to enrolled volunteers in two sequences,
Sequence-I: In the first phase, group-A volunteers on day-1 received oral voriconazole (2 x 200mg, tab, P/O) while group-B volunteers received oral clarithromycin (500mg, tab, P/O) along with voriconazole (2 x 200mg, tab, P/O). A two-week wash-out period was allocated that started on day-2 to day-15 for avoiding the carry-over effect.
Sequence-II: On day-16, the second phase of the trial was conducted in which group-A volunteers received voriconazole (2 x 200mg, tab, P/O) along with clarithromycin (500mg, tab, P/O) while group-B volunteers received Voriz (2 x 200mg, tab, P/O) only. Voriconazole and clarithromycin were administered to the overnight fasted volunteers corresponding to the sequences. All volunteers took the medication with a glass of water (250mL). On day-1 and 16 (treatment days), standard breakfast and lunch were served two and six hours after drug administration to all volunteers, respectively.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single dose, randomized, crossover, open-labeled and two sequence study with a two-week washout period, evaluated the impact of clarithromycin on the pharmacokinetics (PK) profile of voriconazole Pakistani healthy male volunteers.
| Arm | Type | Receives |
|---|---|---|
| Treatment Voriconazole (alone), then Voriconazole + Clarithromycin. | Experimental | Drug: Voriconazole 200 mg x 2 Tablets, Drug: Clarithromycin 500 mg x 1TabletsOn Day-1, Group-A participants first received Voriconazole (alone) (Dose: 400mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral). After a washout period of two weeks. Then, on Day-16 they received Voriconazole (Dose: 400mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral) along with Clarithromycin (Name of medication of Intervention Formulation: Tablet Klaricid, Dose: 500mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral). |
| Treatment Voriconazole + Clarithromycin, then Voriconazole (alone). | Experimental | Drug: Voriconazole 200 mg x 2 Tablets, Drug: Clarithromycin 500 mg x 1TabletsOn Day-1, Group-B participants first received Voriconazole (Dose: 400mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral) along with Clarithromycin (Name of medication of Intervention Formulation: Tablet Klaricid, Dose: 500mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral).After a washout period of two weeks. Then, on Day-16 they received Voriconazole (alone) (Dose: 400mg, Dosage form: Tablet, Frequency: Once (OD), Duration of administration: Single Dose, Kind of administration: Oral). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male Pakistani volunteers in good health aged 18-35 years were enrolled as participants in this study.
- A complete detailed medical history,
- Clinical examination,
- Voriconazole hypersensitivity test,
- Evaluation of various biochemical tests like Blood Glucose Level, Hemoglobin (Hb) Level, Serum Glutamic-Pyruvic Transaminase (SGPT) Or Alanine Amino Transferase and Aspartate (ALT and AST, respectively) Level, Urine Test, Albumin to Creatinine Ratio (ACR) Test, Glomerular Filtration Rate (GFR) Level, etc.
Key exclusion criteria (5 listed)
- Those volunteers were having a history of voriconazole hypersensitivity reaction were excluded from the study.
- Deviation from normal values in the biochemical test report was excluded from the study.
- Having any pathology like chronic renal disease, and hepatic impairment was excluded from the study.
- Having any cardiovascular, gastrointestinal tract, and hematopoietic disorders were excluded from the study.
- Alcohol addicted, smokers and volunteers who cannot sign the permission consent form were excluded from 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 |
|---|---|---|
| Voriconazole 200 mg x 2 TabletsAlso: Vfend®Name of medication of Reference Formulation: Tablets Voriconazole Vfend®, 200 mg by Pfizer, Inc. (USA), (Batch No: 00005505; Mfg. date 09/2016). | Drug | Treatment Voriconazole (alone), then Voriconazole + Clarithromycin., Treatment Voriconazole + Clarithromycin, then Voriconazole (alone). |
| Clarithromycin 500 mg x 1TabletsAlso: klaricid®Name of medication of Intervention Formulation: Tablet Klaricid, 500 mg by Abbott, Lab Pvt. Ltd. (Karachi, Pakistan), Batch No: 81573XU; Mfg. date 10/2017. | Drug | Treatment Voriconazole (alone), then Voriconazole + Clarithromycin., Treatment Voriconazole + Clarithromycin, then Voriconazole (alone). |
Primary outcome
Plasma Concentration of voriconazole
Time frame: At "Day 1" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose and At "Day 16" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose.
Determine the Plasma Concentration particularly the Maximum Plasma Concentration (Cmax) of voriconazole either alone or co-administration with clarithromycin.
Area under the Plasma Concentration versus Time Curve (AUC) of voriconazole
Time frame: At "Day 1" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose and At "Day 16" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose.
Determine the Area under the Plasma Concentration versus Time Curve (AUC) of voriconazole either alone or co-administration with clarithromycin.
1 secondary outcome
Maximum Time to Reach (Cmax) of voriconazole (Tmax)
Time frame: At "Day 1" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose and At "Day 16" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose.
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 18 May 2022.
- Derived from this study: PubMed 37361220Mushtaq M, Fatima K, Ahmad A, Mohamed Ibrahim O, Faheem M, Shah Y. Pharmacokinetic interaction of voriconazole and clarithromycin in Pakistani healthy male volunteers: a single dose, randomized, crossover, open-label study. Front Pharmacol. 2023 Jun 9;14:1134803. doi: 10.3389/fphar.2023.1134803. eCollection 2023.
- Individual participant dataSharing planned: No. To keep the confidentiality of the study participants, however, data would be made available to the Ethics Committee of the institute upon requirement.
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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.
Dr. Mehwish Mushtaq, MPhil principal investigator
Abdul Wali Khan University Mardan (AWKUM), Pakistan / Metrics Research Organization CRO, Pakistan.
Dr. Yasar Shah, Ph.D. study director
Abdul Wali Khan University Mardan (AWKUM), Pakistan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Voriconazole 200 mg x 2 Tablets and Clarithromycin 500 mg x 1Tablets in people with Healthy, run by Abdul Wali Khan University Mardan at 1 site in Pakistan.
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 5 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 18 May 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Plasma Concentration of voriconazole (time frame: At "Day 1" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour post-dose and At "Day 16" Pre-dose, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour 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?
On the ClinicalTrials.gov record for NCT05380245, 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 18 May 2022.