NCT05145621

Oral Bio-equivalence 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Alembic Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2015-10-29
• Primary completion: 2016-01-15
• Completion: 2016-01-15
• First posted: 2021-12-06
• Last updated: 2021-12-21

Locations

1 site across 1 country: Canada