Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers
NCT ID: NCT05572281
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2022-05-18
2022-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence A
tasimelteon liquid suspension formulation then tasimelteon capsule formulation
Tasimelteon Oral Capsule
No additional information
Tasimelteon Oral Suspension
No additional information
Sequence B
tasimelteon capsule formulation then tasimelteon liquid suspension formulation
Tasimelteon Oral Capsule
No additional information
Tasimelteon Oral Suspension
No additional information
Interventions
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Tasimelteon Oral Capsule
No additional information
Tasimelteon Oral Suspension
No additional information
Eligibility Criteria
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Inclusion Criteria
* Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
* Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.
Exclusion Criteria
* Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
* Participants with history of smoking or use of tobacco products in the last 3 months.
* Pregnant or nursing (lactating) women.
18 Years
55 Years
ALL
Yes
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Springfield, Missouri, United States
Countries
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Other Identifiers
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VP-VEC-162-1113
Identifier Type: -
Identifier Source: org_study_id
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