HealthyPhase 1NCT04657744
Bioequivalence Study of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland).
A Phase 1 study testing Sphingomod and Gilenya in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.
Trial summary
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland) in Healthy Human Volunteers Under Fasting Condition. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sphingomod and Gilenya
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2020to 20 Oct 2020
- 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
- Healthy male or female, age 18 to 55 years, inclusive.
- Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
- Medical demographics without evidence of clinically significant deviation from normal medical condition.
- Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- Subject does not have allergy to the drugs under investigation.
- Females should be on a suitable birth control method.
Who cannot join
- Subjects with known allergy to the products tested.
- Subjects whose values of BMI were outside the accepted normal ranges.
- Female subjects who were pregnant or nursing.
- Medical demographics with evidence of clinically significant deviation from normal medical condition.
- Results of laboratory tests which are clinically significant.
- Acute infection within one week preceding first study drug administration.
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- History of drug or alcohol abuse.
- Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
- Subject is on a special diet (for example subject is vegetarian).
- Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
- Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
- Subject has a history of severe diseases which have direct impact on the study.
- Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
- Subject intends to be hospitalized within 3 months after first study drug administration.
- Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland) in Healthy Human Volunteers Under Fasting Condition.
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland) in Healthy Human Volunteers Under Fasting Condition.
Read the detailed description
Open-label, randomized, single dose, two-sequence, two-way crossover study, separated by 49 days washout interval from the first study drug administration.
Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. 30 subjects will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report.
Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e.
The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.
A comprehensive final report will be issued upon the completion of the study.
- Conditions
- Healthy
- Being tested
- Sphingomod, Gilenya
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SphingomodDrug
Also called Gilenya
1 capsule contains 0.5 mg Fingolimod
GilenyaDrug
1 capsule contains 0.5 mg Fingolimod
| Study group | Role | What they receive |
|---|---|---|
| A test | Experimental | Test drug (Sphingomod ) 1 capsule contains 0.5 mg Fingolimod Receives: Drug: Sphingomod |
| B reference | Active comparator | Reference drug (Gilenya) 1 capsule contains 0.5 mg Fingolimod Receives: Drug: Gilenya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximal measured plasma concentration
Measured: Up to 72 hours post dose in each treatment period
Secondary outcomes (1)
Time of the maximum plasma concentration (Tmax)
The amount of time that a drug is present at the maximum concentration in serum
Measured: Up to 72 hours post dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start10 Aug 2020
- Primary completion28 Sep 2020
- Study completion20 Oct 2020
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 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genuine Research Center, Egypt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hikma Pharmaceuticals LLC
- Responsible party
- Sponsor
- Investigators
- Ahmed Elshafeey, Ph.D. Pharma, Study director, Genuine Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657744
- Sponsor's protocol ID
- GRC/1/19/786
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
PubMed 11381568Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.
PubMed 2004861Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
PubMed 3450848
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland) in Healthy Human Volunteers Under Fasting Condition.
- ClinicalTrials.gov ID
- NCT04657744
- Acronym / sponsor ID
- GRC/1/19/786
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Genuine Research Center, EgyptIndustry (pharma, biotech, devices)
- Collaborators
- Hikma Pharmaceuticals LLC
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 8 Dec 2020 (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.
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland) in Healthy Human Volunteers Under Fasting Condition.
Detailed description
Open-label, randomized, single dose, two-sequence, two-way crossover study, separated by 49 days washout interval from the first study drug administration.
Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. 30 subjects will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report.
Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e.
The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.
A comprehensive final report will be issued upon the completion of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A test | Experimental | Drug: SphingomodTest drug (Sphingomod ) 1 capsule contains 0.5 mg Fingolimod |
| B reference | Active comparator | Drug: GilenyaReference drug (Gilenya) 1 capsule contains 0.5 mg Fingolimod |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female, age 18 to 55 years, inclusive.
- Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
- Medical demographics without evidence of clinically significant deviation from normal medical condition.
- Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- Subject does not have allergy to the drugs under investigation.
Key exclusion criteria (15 listed)
- Subjects with known allergy to the products tested.
- Subjects whose values of BMI were outside the accepted normal ranges.
- Female subjects who were pregnant or nursing.
- Medical demographics with evidence of clinically significant deviation from normal medical condition.
- Results of laboratory tests which are clinically significant.
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 |
|---|---|---|
| SphingomodAlso: Gilenya1 capsule contains 0.5 mg Fingolimod | Drug | A test |
| Gilenya1 capsule contains 0.5 mg Fingolimod | Drug | B reference |
Primary outcome
Cmax
Time frame: Up to 72 hours post dose in each treatment period
Maximal measured plasma concentration
1 secondary outcome
Time of the maximum plasma concentration (Tmax)
Time frame: Up to 72 hours post dose in each treatment period
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 8 Dec 2020.
- Background: PubMed 11381568Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
- Background: PubMed 2004861Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.
- Background: PubMed 3450848Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
- 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.
Ahmed Elshafeey, Ph.D. Pharma study director
Genuine Research Center
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 Sphingomod and Gilenya in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.
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 15 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 8 Dec 2020. 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 Egypt. 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?
Cmax (time frame: Up to 72 hours post dose in each treatment period). 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 NCT04657744, 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 8 Dec 2020.