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COMPLETED Phase 1

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

NCT05572281 · View on ClinicalTrials.gov ↗

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

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05572281

The ClinicalTrials.gov registry entry for NCT05572281 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanda Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05572281 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05572281?

The interventions under investigation include: Tasimelteon Oral Suspension (DRUG), Tasimelteon Oral Capsule (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05572281?

This trial is sponsored by Vanda Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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