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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: Completed Phase 1 study of Healthy, sponsored by Vanda Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
as measured by plasma concentrations
Conditions Studied
Interventions
- DRUG Tasimelteon Oral Suspension
- DRUG Tasimelteon Oral Capsule
Study Locations (1)
Missouri
- Vanda Investigational Site - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-05-18 |
| Est. Completion | 2022-06-15 |
| Phase | Phase 1 |
What the finished NCT05572281 record still lists
NCT05572281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05572281's enrollment target sits among peer trials
36 595th of 1090 higher than 469 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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