- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05572281
Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers
March 19, 2024 updated by: Vanda Pharmaceuticals
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Springfield, Missouri, United States, 65802
- Vanda Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy male and/or female participants between 18 to 55 years (inclusive).
- 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 with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence A
tasimelteon liquid suspension formulation then tasimelteon capsule formulation
|
No additional information
No additional information
|
Experimental: Sequence B
tasimelteon capsule formulation then tasimelteon liquid suspension formulation
|
No additional information
No additional information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation
Time Frame: 8 hours
|
as measured by plasma concentrations
|
8 hours
|
Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon
Time Frame: 7 days
|
as measured by incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2022
Primary Completion (Actual)
June 15, 2022
Study Completion (Actual)
June 15, 2022
Study Registration Dates
First Submitted
July 5, 2022
First Submitted That Met QC Criteria
October 5, 2022
First Posted (Actual)
October 7, 2022
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- VP-VEC-162-1113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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