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

NCT06084663 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-12-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Principal Investigators

  • Hakan Gürpınar · Humanis Saglık

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2023-02-25
Completion
2023-04-25

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06084663 on ClinicalTrials.gov