Oral Bio-equivalence Study

NCT05145621 | Completed Phase 1

• 1 other identifier: AMC-P6-855
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cmax- Peak Plasma concentration

  Peak Plasma concentration of Test product should be comparable with Reference product

  upto 72 hours

• AUC0-72

  Area Under the Concentration of Test product should be comparable with Reference product

  upto 72 hours

Study Arms (2)

Test

ACTIVE COMPARATOR

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

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)

Drug: Fingolimod 0.5 mg capsules- Test drug

Interventions

Fingolimod 0.5 mg capsules- Test drug 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.

Also known as: Fingolimod 0.5 mg capsules- Reference drug

Reference; Test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers meeting all of the following criteria will be considered for enrollment in the study:
• \. 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:
• bilateral oophorectomy; and
• absence of menses for at least 3 months; and
• FSH levels ≥ 40 mIU/mL at screening; or

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Alembic Pharmaceuticals Ltd.: lead

Study Sites (1)

Algorithme Pharma Inc.

Mount Royal, Quebec, H3P 3H5, Canada

Location

MeSH Terms

Interventions

Fingolimod Hydrochloride

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Eric Sicard, M.D.

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two way crossover

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 6, 2021
• Study Start: October 29, 2015
• Primary Completion: January 15, 2016
• Study Completion: January 15, 2016
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

CA (1)