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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tasimelteon Oral Capsule; Drug: Tasimelteon Oral Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT05572281

VP-VEC-162-1113

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Sequence A

Experimental group

Description:

tasimelteon liquid suspension formulation then tasimelteon capsule formulation

Treatment:

Drug: Tasimelteon Oral Capsule

Drug: Tasimelteon Oral Suspension

Sequence B

Experimental group

Description:

tasimelteon capsule formulation then tasimelteon liquid suspension formulation

Treatment:

Drug: Tasimelteon Oral Capsule

Drug: Tasimelteon Oral Suspension