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

Conditions

• Psoriasis and Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Apremilast 30 mg Tablets — DRUG
  Each film-coated tablet contains 30 mg of apremilast
• Otezla 30 mg film-coated tablets — DRUG
  Each film-coated tablet contains 30 mg of apremilast

Study Details

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

Key Dates

First listed

Oct 16, 2023

Start date

Feb 15, 2023

Status verified

Dec 2023

Primary completion

Feb 25, 2023

Completion

Apr 25, 2023

Study Design

Enrollment

36 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Arms

• Experimental: Apremilast 30 mg Tablets
  One tablet was administered orally to each subject as per randomization schedule in each period
• Active Comparator: Otezla 30 mg film-coated tablets
  One tablet was administered orally to each subject as per randomization schedule in each period

Primary Outcome Measure

Cmax [ Time Frame: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000 and 48.000 hours ]