NCT03317236

Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.

Bioequivalence Study of Quetiapine in Healthy Volunteers, After Administering a Single Dose of the Test Extended Release Formulation, Kemoter XR With Respect to the Reference Product, Etiasel XR ® From AstraZeneca S.A.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Laboratorio Elea Phoenix S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way crossover design.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Quetiapine	A fixed 50 mg exteded release formulation.

Timeline

• Start date: 2017-03-13
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2017-10-23
• Last updated: 2017-10-23

Locations

1 site across 1 country: Argentina