NCT05572281

Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers

An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of Tasimelteon Capsule Formulation Relative to Tasimelteon Liquid Suspension Formulation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tasimelteon Oral Capsule	No additional information
DRUG	Tasimelteon Oral Suspension	No additional information

Timeline

• Start date: 2022-05-18
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2022-10-07
• Last updated: 2024-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study