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Oral Bio-equivalence Study

NCT05145621 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-12-21

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Alembic Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, M.D. · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-29
Primary Completion
2016-01-15
Completion
2016-01-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05145621 on ClinicalTrials.gov