NCT06084663

Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Cross Over Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition

Conditions

• Psoriasis and Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Apremilast 30 mg Tablets	Each film-coated tablet contains 30 mg of apremilast
DRUG	Otezla 30 mg film-coated tablets	Each film-coated tablet contains 30 mg of apremilast

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-02-25
• Completion: 2023-04-25
• First posted: 2023-10-16
• Last updated: 2023-12-13

Locations

1 site across 1 country: India