Oral Bio-equivalence Study

NCT ID: NCT05145621

Last Updated: 2021-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-29
• Study Completion Date: 2016-01-15

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test

Fingolimod 0.5 mg capsules - (administered as 3 x Fingolimod 0.5 mg capsules)

Group Type: ACTIVE_COMPARATOR

Fingolimod 0.5 mg capsules- Test drug

Intervention Type: 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.

Reference

Fingolimod 0.5 mg capsules -(administered as 3 x Fingolimod 0.5 mg capsules)

Group Type: ACTIVE_COMPARATOR

Fingolimod 0.5 mg capsules- Test drug

Intervention Type: 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.

Interventions

Fingolimod 0.5 mg capsules- Test 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.

Intervention Type: DRUG

Other Intervention Names

Fingolimod 0.5 mg capsules- Reference drug

Eligibility Criteria

Inclusion Criteria

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:

1. Physiological postmenopausal status, defined as the following:

1. no menses for at least one year (absence of menses should not be due to lactational amenorrhea); and

2. FSH levels ≥ 40 mIU/mL at screening; or

2. Surgical postmenopausal status, defined as the following:

1. bilateral oophorectomy; and

2. absence of menses for at least 3 months; and

3. FSH levels ≥ 40 mIU/mL at screening; or

Exclusion Criteria

Volunteers presenting any of the following will not be included in the study:

1. Difficulty donating blood

2. Difficulty swallowing solids like tablets or capsules

3. Seated pulse rate less than 60 bpm or more than 100 bpm at screening

4. 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

5. 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

6. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability

7. History or presence of significant cardiovascular, respiratory, pulmonary, hepatic, renal, gastrointestinal, ophthalmological, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease

8. Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases or disorder

9. Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTc > 440 msec)

10. History of using live attenuated vaccines within 56 days before day 1 of this study

11. Immunization with a vaccine within 28 days before day 1 of this study

12. Use of immunosuppressant in the 28 days before day 1 of this study

13. 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)

14. Any clinically significant illness in the previous 28 days before day 1 of this study

15. 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

16. Any history of latent or active tuberculosis and/or prophylaxis for tuberculosis according to the TB Medical History screening questionnaire (see Appendix 1)

17. Positive tuberculin blood or skin test

18. Herpes IgG (Type 1) and/or IgG (Type 2) antibody levels that may predispose to undesired effects, as per medical judgment

19. Positive urine screening of drugs of abuse

20. Positive alcohol breath test

21. Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B)(hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests

22. Females who are pregnant according to a positive pregnancy test

23. 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

24. 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

25. Volunteers who donated 50 mL or more of blood in the previous 28 days before day 1 of this study

26. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alembic Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Sicard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Algorithme Pharma Inc

Locations

Algorithme Pharma Inc.

Mount Royal, Quebec, Canada

Countries

Canada

Other Identifiers

AMC-P6-855

Identifier Type: -

Identifier Source: org_study_id