Healthy VolunteersPhase 1NCT03757338
Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod
A Phase 1 study testing Fingolimod Reference Formulation and Fingolimod Test Formulation in people with Healthy Volunteers, run by Asofarma S.A.I. y C. at 1 site in New Zealand.
Trial summary
The study evaluates the bioequivalence of the Test formulation, 0.5 mg Fingolimod HCl capsule (Asofarma S.A.I. y C. on behalf of Tolmar, Batch No. 22264), relative to that of the Reference formulation, 0.5 mg Gilenya® (fingolimod) capsule (Novartis Pharmaceuticals, Batch No. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Fingolimod Reference Formulation and Fingolimod Test Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteNew Zealand
- Study dates
- 23 Oct 2015to 26 Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent for the participation in the study.
- Aged between 18 and 45 years, inclusive.
- All females of childbearing potential must have a negative serum pregnancy test 3 days prior to dosing in both study periods.
- Females of childbearing potential must agree to acceptable method of contraception (as agreed with the study doctor) or abstain from sexual activity during the study.
- Body Mass Index (BMI) within 18 - 30 kg/m2, inclusive, with body mass above 45 kg.
- Normal, healthy individuals as determined by medical history, physical examination, vital signs, ECG and laboratory tests.
Show all 10Show fewer
- Non-smoker (for at least 6 months). This includes all tobacco products and nicotine containing patches and gums.
- Must abstain from consuming alcohol and caffeine and remain chocolate free for 48 hours prior to the study and throughout each study period (i.e. until 72 hours post-dosing in each period).
- Non-consumption of grapefruits or oranges, grapefruit and/or orange juice and any grapefruit and/or orange products for 1 week prior to the study and throughout the study (i.e. until 72 hours after receiving the final dose).
- Subjects must agree and be able to follow the study procedures, in the Investigator's opinion.
Who cannot join
- Known hypersensitivity to fingolimod, its analogues or excipients of the tested drug or the reference drug, lactose malabsorption, glucose-galactose malabsorption or Lapp lactase deficiency.
- Aggravated history of allergies (evidence of anaphylactic shock or Quincke's edema).
- History of gastrointestinal (GI), hepatic or renal abnormality or any other abnormality, which, in the Investigator's opinion, may affect absorption, distribution, metabolism and excretion of the IMPs (e.g. operative interventions to the GI tract other than appendectomy).
- Pregnant or breastfeeding females.
- Acute infectious diseases within 4 weeks before the study start.
- Significant cardio-vascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic, ophthalmologic or dermatologic disease.
Show all 26Show fewer
- Subjects who have had any severe eye problems or conditions especially inflammation of the eye, such as uveitis.
- Vital signs measured in the seated position: heart rate <50 or >90 beats per minute or systolic BP <90 mmHg or >160 mmHg or diastolic BP <50 mmHg or >90 mmHg.
- Subjects with prolonged QTc interval (defined as >450 msec for males and >470 msec for females).
- Any clinically significant laboratory abnormalities at screening, including potassium, bilirubin, asparte transaminase (AST) and alanine transaminase (ALT) blood levels.
- Evidence of routine consumption of more than 10 units of alcohol per week within 6 months before screening (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of wine or 50 ml of spirit), positive breath test for alcohol or alcohol consumption within 48 hours prior to the study start.
- Evidence of any drug abuse within one year prior to the study start or positive urine drug and prohibited medication screen.
- Concomitant drug therapy of any kind with the exception of prescribed hormonal contraceptives.
- Having received vaccinations within 1 month prior to dosing or any planned vaccination within 2 months of the last dose of fingolimod.
- Administration of any medication that can cause a significant effect onto hemodynamics or liver function within 30 days prior to the study start.
- Administration of any medications which can induce or inhibit the drug hepatic metabolism via CYP1A2, CYP2D6, CYP2C8, CYP3A4 and CYP17 (hepatic metabolism inducers include barbiturates, carbamazepine, phenytoin, glucocorticosteroids, omeprazole; hepatic metabolism inhibitors include antidepressants, cimetidine, diltiazem, macrolides, imidazole, neuroleptics, verapamil, fluoroquinolones, antihistamine drugs), as well as herbal preparations and extracts within 30 days prior to the study start.
- Administration of any injectable deposit (sustained release) formulations or drug implants within 3 months prior to the study drug administration.
- Participation in any clinical study within 60 days prior to the study start.
- Donation or loss of more than 450 ml of blood within 2 months prior to the screening visit.
- Possible difficulties with study drug swallowing.
- History of tuberculosis or participation in the tuberculosis control program.
- Herpes simplex or varicella zoster virus infection including cold sore, genital herpes, chickenpox or shingles.
- Human Immunodeficiency Virus (HIV) positive test, positive test for hepatitis B or C.
- Other acute or chronic medical or mental conditions, laboratory abnormalities which may increase risk associated with the study participation or with study drug administration or which may affect interpretation of the study results and, in the Investigator's opinion, make the subject non-eligible for participation in this study.
- Inability of the subject to follow the requirements of the study.
- Employees of the study Sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Dose, Crossover, Bioequivalence Study of Fingolimod 0.5 mg Capsule (Asofarma S.A.I. y C., Argentina) Compared With Gilenya 0.5 mg Capsule (Novartis Pharmaceuticals, Australia Pty Ltd) in Fasting Healthy Subjects
The study evaluates the bioequivalence of the Test formulation, 0.5 mg Fingolimod HCl capsule (Asofarma S.A.I. y C. on behalf of Tolmar, Batch No. 22264), relative to that of the Reference formulation, 0.5 mg Gilenya® (fingolimod) capsule (Novartis Pharmaceuticals, Batch No. S0099), following oral administration of a single oral dose of 3 x 0.5 mg in healthy, adult, male and female subjects under fasting conditions.
Read the detailed description
This was a single centre, single dose, blinded, two treatment, two period, two sequence, two-way crossover, randomized study conducted under medical supervision at Zenith Technology Corporation Limited's Clinical Site and involving 32 healthy adult subjects.
All subjects received either the Test or the Reference product under fasting conditions in each of the two treatment periods. In Period 1, one half of the subjects (16) were scheduled to receive 3 x 0.5 mg Fingolimod HCl capsules (Test); and one half of the subjects (16) were scheduled to receive 3 x 0.5 mg Gilenya® capsules (Reference). Each subject was scheduled to receive the alternate treatment in Period 2.
The two treatments were administered with 240 ml of ambient-temperature water after an overnight fast of at least 10 hours. Subjects did not receive any food until at least 4 hours post-dose. The capsules were swallowed whole.
During each study period, subjects were confined to the Zenith Clinical Site from at least 12 hours prior to drug administration, until after the 24-hour post-dose blood draw. Blood samples (18 x 10 ml) were collected at specified intervals during the in-house period from pre-dose (0 hours) out to 24 hours post-dose. Subjects returned to Zenith premises for the collection of additional blood samples (4 x 10 ml) at 32, 48, 56 and 72 hours post-dose. A total of 22 x 10 ml blood samples were collected in each study period.
The doses in the two treatment periods were separated by a washout period of at least 42 days and the project duration was 46 days for subject dosing and blood sampling over two periods.
- Conditions
- Healthy Volunteers
- Being tested
- Fingolimod Reference Formulation, Fingolimod Test Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingolimod Reference FormulationDrug
Also called Gylenia®
To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the reference product produced by Novartis Pharmaceutical with the proposed test product manufactured by Asofarma S.A.I. y C. in healthy volunteers, under fasted conditions.
Fingolimod Test FormulationDrug
Also called Lebrina®
To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the proposed test product manufactured by Asofarma S.A.I. y C. with the reference product produced by Novartis Pharmaceutical in healthy volunteers, under fasted conditions.
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod Reference Formulation | Active comparator | 0.5 mg Fingolimod capsule (manufactured by Novartis, Batch No. S0099), orally administered as a single dose of 3 x 0.5 mg capsules. Receives: Drug: Fingolimod Reference Formulation |
| Fingolimod Test Formulation | Experimental | 0.5 mg Fingolimod capsule (manufactured by manufactured by Asofarma S.A.I. y C. on behalf of Tolmar, Batch No. 22264), orally administered as a single dose of 3 x 0.5 mg capsules. Receives: Drug: Fingolimod Test Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fingolimod plasma Cmax (maximum plasma concentration) when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Fingolimod plasma Cmax will be calculated based on plasma Fingolimod concentrations within 1 hour pre-dose (time 0) and at 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post-dose.
Measured: Measurement within 72 hours post-dose.
Fingolimod AUC0-t (area under the plasma concentration-time curve from time of intake until the last quantifiable concentration) when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Fingolimod AUC0-t will be calculated based on plasma Fingolimod concentrations within 1 hour pre-dose (time 0) and at 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post-dose.
Measured: Measurement within 72 hours post-dose.
Fingolimod AUC0-∞ (area under the plasma concentration-time curve from time of intake until infinity) when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Fingolimod AUC0-∞ will be calculated based on plasma Fingolimod concentrations within 1 hour pre-dose (time 0) and at 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post-dose.
Measured: Measurement within 72 hours post-dose.
Secondary outcomes (2)
Fingolimod elimination t1/2 (elimination half-life), when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Fingolimod t1/2 will be calculated based on plasma Fingolimod concentrations within 1 hour pre-dose (time 0) and at 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post-dose.
Measured: Measurement within 72 hours post-dose.
Fingolimod Tmax (time to Cmax), when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Fingolimod Tmax will be calculated based on plasma Fingolimod concentrations within 1 hour pre-dose (time 0) and at 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post-dose.
Measured: Measurement within 72 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start23 Oct 2015
- Primary completion26 Jan 2016
- Study completion26 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single centre, single dose, blinded, two treatment, two period, two sequence, two-way crossover, randomized study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asofarma S.A.I. y C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zenith Technology Corporation Limited
- Responsible party
- Sponsor
- Investigators
- Noelyn A Hung, MB ChB, Principal investigator, Zenith Technology Corporation Ltd, 156 Frederick Street, Dunedin, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757338
- Sponsor's protocol ID
- ACTRN12615001055594
- Other IDs
- ZPS-578 (C15-020-LBB)
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Food and Drug Administration, USA. Bioequivalence Recommendations for fingolimod, Aug 2011.
Australian Product Information, Gilenya, 1 April 2015
Hung NA, Costa FG, Hung CT, Rosenberg ME. Bioequivalence Study of 2 Capsule Formulations of Fingolimod 0.5 mg Assessing Both Parent Drug and Active Metabolite in New Zealand Healthy Subjects (Truncated Design). Clin Pharmacol Drug Dev. 2020 Jul;9(5):610-620. doi: 10.1002/cpdd.813. Epub 2020 May 28.
PubMed 32468719
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Dose, Crossover, Bioequivalence Study of Fingolimod 0.5 mg Capsule (Asofarma S.A.I. y C., Argentina) Compared With Gilenya 0.5 mg Capsule (Novartis Pharmaceuticals, Australia Pty Ltd) in Fasting Healthy Subjects
- ClinicalTrials.gov ID
- NCT03757338
- Acronym / sponsor ID
- ACTRN12615001055594
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Asofarma S.A.I. y C.Industry (pharma, biotech, devices)
- Collaborators
- Zenith Technology Corporation Limited
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 26 Jan 2016 (actual)
- Study completion
- 26 Jan 2016 (actual)
- First posted
- 28 Nov 2018 (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 evaluates the bioequivalence of the Test formulation, 0.5 mg Fingolimod HCl capsule (Asofarma S.A.I. y C. on behalf of Tolmar, Batch No. 22264), relative to that of the Reference formulation, 0.5 mg Gilenya® (fingolimod) capsule (Novartis Pharmaceuticals, Batch No. S0099), following oral administration of a single oral dose of 3 x 0.5 mg in healthy, adult, male and female subjects under fasting conditions.
Detailed description
This was a single centre, single dose, blinded, two treatment, two period, two sequence, two-way crossover, randomized study conducted under medical supervision at Zenith Technology Corporation Limited's Clinical Site and involving 32 healthy adult subjects.
All subjects received either the Test or the Reference product under fasting conditions in each of the two treatment periods. In Period 1, one half of the subjects (16) were scheduled to receive 3 x 0.5 mg Fingolimod HCl capsules (Test); and one half of the subjects (16) were scheduled to receive 3 x 0.5 mg Gilenya® capsules (Reference). Each subject was scheduled to receive the alternate treatment in Period 2.
The two treatments were administered with 240 ml of ambient-temperature water after an overnight fast of at least 10 hours. Subjects did not receive any food until at least 4 hours post-dose. The capsules were swallowed whole.
During each study period, subjects were confined to the Zenith Clinical Site from at least 12 hours prior to drug administration, until after the 24-hour post-dose blood draw. Blood samples (18 x 10 ml) were collected at specified intervals during the in-house period from pre-dose (0 hours) out to 24 hours post-dose. Subjects returned to Zenith premises for the collection of additional blood samples (4 x 10 ml) at 32, 48, 56 and 72 hours post-dose. A total of 22 x 10 ml blood samples were collected in each study period.
The doses in the two treatment periods were separated by a washout period of at least 42 days and the project duration was 46 days for subject dosing and blood sampling over two periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single centre, single dose, blinded, two treatment, two period, two sequence, two-way crossover, randomized study.
| Arm | Type | Receives |
|---|---|---|
| Fingolimod Reference Formulation | Active comparator | Drug: Fingolimod Reference Formulation0.5 mg Fingolimod capsule (manufactured by Novartis, Batch No. S0099), orally administered as a single dose of 3 x 0.5 mg capsules. |
| Fingolimod Test Formulation | Experimental | Drug: Fingolimod Test Formulation0.5 mg Fingolimod capsule (manufactured by manufactured by Asofarma S.A.I. y C. on behalf of Tolmar, Batch No. 22264), orally administered as a single dose of 3 x 0.5 mg capsules. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Written informed consent for the participation in the study.
- Aged between 18 and 45 years, inclusive.
- All females of childbearing potential must have a negative serum pregnancy test 3 days prior to dosing in both study periods.
- Females of childbearing potential must agree to acceptable method of contraception (as agreed with the study doctor) or abstain from sexual activity during the study.
- Body Mass Index (BMI) within 18 - 30 kg/m2, inclusive, with body mass above 45 kg.
Key exclusion criteria (26 listed)
- Known hypersensitivity to fingolimod, its analogues or excipients of the tested drug or the reference drug, lactose malabsorption, glucose-galactose malabsorption or Lapp lactase deficiency.
- Aggravated history of allergies (evidence of anaphylactic shock or Quincke's edema).
- History of gastrointestinal (GI), hepatic or renal abnormality or any other abnormality, which, in the Investigator's opinion, may affect absorption, distribution, metabolism and excretion of the IMPs (e.g. operative interventions to the GI tract other than appendectomy).
- Pregnant or breastfeeding females.
- Acute infectious diseases within 4 weeks before the study start.
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 |
|---|---|---|
| Fingolimod Reference FormulationAlso: Gylenia®To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the reference product produced by Novartis Pharmaceutical with the proposed test product manufactured by Asofarma S.A.I. y C. in healthy volunteers, under fasted conditions. | Drug | Fingolimod Reference Formulation |
| Fingolimod Test FormulationAlso: Lebrina®To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the proposed test product manufactured by Asofarma S.A.I. y C. with the reference product produced by Novartis Pharmaceutical in healthy volunteers, under fasted conditions. | Drug | Fingolimod Test Formulation |
Primary outcome
Fingolimod plasma Cmax (maximum plasma concentration) when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Time frame: Measurement within 72 hours post-dose.
Fingolimod plasma Cmax will be calculated based on plasma Fingolimod concentrations within 1 hour pre-dose (time 0) and at 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post-dose.
Fingolimod AUC0-t (area under the plasma concentration-time curve from time of intake until the last quantifiable concentration) when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Time frame: Measurement within 72 hours post-dose.
Fingolimod AUC0-t will be calculated based on plasma Fingolimod concentrations within 1 hour pre-dose (time 0) and at 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post-dose.
Fingolimod AUC0-∞ (area under the plasma concentration-time curve from time of intake until infinity) when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Time frame: Measurement within 72 hours post-dose.
Fingolimod AUC0-∞ will be calculated based on plasma Fingolimod concentrations within 1 hour pre-dose (time 0) and at 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post-dose.
2 secondary outcomes
Fingolimod elimination t1/2 (elimination half-life), when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Time frame: Measurement within 72 hours post-dose.
Fingolimod Tmax (time to Cmax), when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product.
Time frame: Measurement within 72 hours 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 29 Nov 2018.
- BackgroundFood and Drug Administration, USA. Bioequivalence Recommendations for fingolimod, Aug 2011.
- BackgroundAustralian Product Information, Gilenya, 1 April 2015
- Derived from this study: PubMed 32468719Hung NA, Costa FG, Hung CT, Rosenberg ME. Bioequivalence Study of 2 Capsule Formulations of Fingolimod 0.5 mg Assessing Both Parent Drug and Active Metabolite in New Zealand Healthy Subjects (Truncated Design). Clin Pharmacol Drug Dev. 2020 Jul;9(5):610-620. doi: 10.1002/cpdd.813. Epub 2020 May 28.
- Individual participant dataSharing planned: No
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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.
Noelyn A Hung, MB ChB principal investigator
Zenith Technology Corporation Ltd, 156 Frederick Street, Dunedin, New Zealand
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 Fingolimod Reference Formulation and Fingolimod Test Formulation in people with Healthy Volunteers, run by Asofarma S.A.I. y C. at 1 site in New Zealand.
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 10 inclusion and 26 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 29 Nov 2018. 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 New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fingolimod plasma Cmax (maximum plasma concentration) when administered as a single oral dose of 3 x 0.5 mg capsule of the test versus reference product. (time frame: Measurement within 72 hours post-dose.). The study lists 3 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 NCT03757338, which also lists 3 linked publications.
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 29 Nov 2018.