BioequivalencePhase 1NCT05145621
Oral Bio-equivalence Study
A Phase 1 study testing Fingolimod 0.5 mg capsules- Test drug in people with Bioequivalence and Safety, run by Alembic Pharmaceuticals Ltd. at 1 site in Canada.
Trial summary
Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects Under Fasting Conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, Safety
- What is being tested?
- Fingolimod 0.5 mg capsules- Test drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 29 Oct 2015to 15 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
- Volunteers meeting all of the following criteria will be considered for enrollment in the study:
- 1. Availability for the entire study period 2. Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee 3. Male or female volunteer 4. A female volunteer must meet one of the following criteria:
- Physiological postmenopausal status, defined as the following:
- no menses for at least one year (absence of menses should not be due to lactational amenorrhea); and
- FSH levels ≥ 40 mIU/mL at screening; or
- Surgical postmenopausal status, defined as the following:
Show all 10Show fewer
- bilateral oophorectomy; and
- absence of menses for at least 3 months; and
- FSH levels ≥ 40 mIU/mL at screening; or
- Hysterectomy with FSH levels ≥ 40 mIU/mL at screening If the postmenopausal volunteer has an FSH of < 40 mIU/mL, but meets the above criteria in either (1), (2) or (3) and all the other inclusion criteria in section 5.2, the volunteer may be included in the study if the estradiol serum level measured at screening is equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, inclusion of the volunteer will be based on medical judgment. 5. Volunteer aged of at least 18 years but not older than 45 years 6. Volunteer with a BMI greater than or equal to 18.50 kg/m2 and below 30.00 kg/m2 7. Volunteer with a minimum body weight of at least 60 kg 8. Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking and/or using tobacco/tobacco-containing products for at least 6 months before day 1 of this study 9. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance 10. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, ECG and urinalysis) 11. Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer 12. Volunteer agrees not to participate in another clinical study for up to 10 weeks following the last drug administration The ICF must be signed by all volunteers prior to their participation in the study.
Who cannot join
- Volunteers presenting any of the following will not be included in the study:
- Difficulty donating blood
- Difficulty swallowing solids like tablets or capsules
- Seated pulse rate less than 60 bpm or more than 100 bpm at screening
- History of significant hypersensitivity to fingolimod or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
Show all 27Show fewer
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
- History or presence of significant cardiovascular, respiratory, pulmonary, hepatic, renal, gastrointestinal, ophthalmological, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases or disorder
- Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTc > 440 msec)
- History of using live attenuated vaccines within 56 days before day 1 of this study
- Immunization with a vaccine within 28 days before day 1 of this study
- Use of immunosuppressant in the 28 days before day 1 of this study
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study
- Any history of latent or active tuberculosis and/or prophylaxis for tuberculosis according to the TB Medical History screening questionnaire (see Appendix 1)
- Positive tuberculin blood or skin test
- Herpes IgG (Type 1) and/or IgG (Type 2) antibody levels that may predispose to undesired effects, as per medical judgment
- Positive urine screening of drugs of abuse
- Positive alcohol breath test
- Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B)(hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
- Females who are pregnant according to a positive pregnancy test
- Volunteers who took an Investigational Product (in another clinical trial) with a long half-life (≥120 hours) in the previous 3 months before day 1 of this study
- Volunteers who took an Investigational Product (in another clinical trial) with a half-life less than 120 hours in the previous 28 days before day 1 of this study or who have already participated in this clinical study
- Volunteers who donated 50 mL or more of blood in the previous 28 days before day 1 of this study
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects Under Fasting Conditions
Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects Under Fasting Conditions.
Objective: The objective of this study is to compare the oral bioavailability and characterize the pharmacokinetic profile of the test formulation relative to that of reference formulation in healthy, adult, human subjects under fasting conditions and to assess the bioequivalence.
- Conditions
- Bioequivalence, Safety
- Being tested
- Fingolimod 0.5 mg capsules- Test drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingolimod 0.5 mg capsules- Test drugDrug
Also called Fingolimod 0.5 mg capsules- Reference drug
An oral dose of the assigned formulation (3 capsules) will be administered in the morning to subjects with about 240 mL of water at ambient temperature according to the randomization scheme.
| Study group | Role | What they receive |
|---|---|---|
| Test | Active comparator | Fingolimod 0.5 mg capsules - (administered as 3 x Fingolimod 0.5 mg capsules) Receives: Drug: Fingolimod 0.5 mg capsules- Test drug |
| Reference | Active comparator | Fingolimod 0.5 mg capsules -(administered as 3 x Fingolimod 0.5 mg capsules) Receives: Drug: Fingolimod 0.5 mg capsules- Test drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax- Peak Plasma concentration
Peak Plasma concentration of Test product should be comparable with Reference product
Measured: upto 72 hours
AUC0-72
Area Under the Concentration of Test product should be comparable with Reference product
Measured: upto 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start29 Oct 2015
- Primary completion15 Jan 2016
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Model description
- two way crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alembic Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, M.D., Principal investigator, Algorithme Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145621
- Sponsor's protocol ID
- AMC-P6-855
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2015
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05145621
- Acronym / sponsor ID
- AMC-P6-855
- Conditions
- Bioequivalence, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alembic Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- 15 Jan 2016 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 6 Dec 2021 (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.
Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects Under Fasting Conditions.
Objective: The objective of this study is to compare the oral bioavailability and characterize the pharmacokinetic profile of the test formulation relative to that of reference formulation in healthy, adult, human subjects under fasting conditions and to assess the bioequivalence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two way crossover
| Arm | Type | Receives |
|---|---|---|
| Test | Active comparator | Drug: Fingolimod 0.5 mg capsules- Test drugFingolimod 0.5 mg capsules - (administered as 3 x Fingolimod 0.5 mg capsules) |
| Reference | Active comparator | Drug: Fingolimod 0.5 mg capsules- Test drugFingolimod 0.5 mg capsules -(administered as 3 x Fingolimod 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)
- Volunteers meeting all of the following criteria will be considered for enrollment in the study:
- 1. Availability for the entire study period 2. Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee 3. Male or female volunteer 4. A female volunteer must meet one of the following criteria:
- Physiological postmenopausal status, defined as the following:
- Surgical postmenopausal status, defined as the following:
- Hysterectomy with FSH levels ≥ 40 mIU/mL at screening If the postmenopausal volunteer has an FSH of < 40 mIU/mL, but meets the above criteria in either (1), (2) or (3) and all the other inclusion criteria in section 5.2, the volunteer may be included in the study if the estradiol serum level measured at screening is equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, inclusion of the volunteer will be based on medical judgment. 5. Volunteer aged of at least 18 years but not older than 45 years 6. Volunteer with a BMI greater than or equal to 18.50 kg/m2 and below 30.00 kg/m2 7. Volunteer with a minimum body weight of at least 60 kg 8. Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking and/or using tobacco/tobacco-containing products for at least 6 months before day 1 of this study 9. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance 10. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, ECG and urinalysis) 11. Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer 12. Volunteer agrees not to participate in another clinical study for up to 10 weeks following the last drug administration The ICF must be signed by all volunteers prior to their participation in the study.
Key exclusion criteria (27 listed)
- Difficulty donating blood
- Difficulty swallowing solids like tablets or capsules
- Seated pulse rate less than 60 bpm or more than 100 bpm at screening
- History of significant hypersensitivity to fingolimod or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
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 0.5 mg capsules- Test drugAlso: Fingolimod 0.5 mg capsules- Reference drugAn oral dose of the assigned formulation (3 capsules) will be administered in the morning to subjects with about 240 mL of water at ambient temperature according to the randomization scheme. | Drug | Reference, Test |
Primary outcome
Cmax- Peak Plasma concentration
Time frame: upto 72 hours
Peak Plasma concentration of Test product should be comparable with Reference product
AUC0-72
Time frame: upto 72 hours
Area Under the Concentration of Test product should be comparable with Reference product
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 21 Dec 2021.
Related trials for Bioequivalence
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
Active, not recruitingPhase 1
Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions
Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP)
RecruitingPhase 1
Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients
Bioequivalence
Not yet recruitingPhase 1
Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants
Bioequivalence
Not yet recruiting
Coffee Bioequivalence Trial
Liver Functions, Bioequivalence
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.
Eric Sicard, M.D. principal investigator
Algorithme Pharma Inc
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 0.5 mg capsules- Test drug in people with Bioequivalence and Safety, run by Alembic Pharmaceuticals Ltd. at 1 site in Canada.
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 27 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 21 Dec 2021. 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 Canada. 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- Peak Plasma concentration (time frame: upto 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021; AzTrials last refreshed its copy on 29 Oct 2026.