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NCT05572281 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy, sponsored by Vanda Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT05572281 is a Phase 1 study of Healthy that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 36 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05572281, a Phase 1 study of Healthy, has completed, sponsored by Vanda Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DRUG Tasimelteon Oral Suspension
  • DRUG Tasimelteon Oral Capsule

Study Locations (1)

Missouri

  • Vanda Investigational Site - Springfield

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2022-05-18
Est. Completion 2022-06-15
Phase Phase 1

Sponsor

Vanda Pharmaceuticals

68 total trials

What the Registry Record Tells You About NCT05572281

The ClinicalTrials.gov registry entry for NCT05572281 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The listed sponsor is Vanda Pharmaceuticals, which has 68 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Tasimelteon Oral Suspension is the first listed.

NCT05572281 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT05572281 about?

NCT05572281 is a clinical study titled "Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers". 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.

What is the current status of trial NCT05572281?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-05-18. Estimated completion is 2022-06-15.

What conditions does trial NCT05572281 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT05572281?

The interventions under investigation include: Tasimelteon Oral Suspension (DRUG), Tasimelteon Oral Capsule (DRUG).

Who is sponsoring clinical trial NCT05572281?

This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05572281 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.