Trials Sponsors Conditions Drugs Pricing

Conditions

Psoriasis and Psoriatic Arthritis

Outcome Measures

Primary Outcomes (2)

Cmax
Maximum plasma concentration
The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000,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
AUC0-t
Area under the plasma concentration curve from administration to last observed concentration at time t
The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000,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

Secondary Outcomes (1)

AUC0-∞
The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000,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

Study Arms (2)

Apremilast 30 mg Tablets

EXPERIMENTAL

One tablet was administered orally to each subject as per randomization schedule in each period

Drug: Apremilast 30 mg TabletsDrug: Otezla 30 mg film-coated tablets

Otezla 30 mg film-coated tablets

ACTIVE COMPARATOR

One tablet was administered orally to each subject as per randomization schedule in each period

Drug: Apremilast 30 mg TabletsDrug: Otezla 30 mg film-coated tablets

Interventions

Apremilast 30 mg TabletsDrug

Each film-coated tablet contains 30 mg of apremilast

Apremilast 30 mg TabletsOtezla 30 mg film-coated tablets

Otezla 30 mg film-coated tabletsDrug

Each film-coated tablet contains 30 mg of apremilast

Apremilast 30 mg Tablets

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Non-smoker, Normal, healthy, adult, human, subjects between 18 and 45 years of age (both inclusive).
Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg/height in m2.

Sponsors & Collaborators

Humanis Saglık Anonim Sirketi
Industrylead

Study Sites (1)

Lambda Therapeutic Research Ltd.

Ahmedabad, Gujarat, 382481, India

MeSH Terms

Conditions

PsoriasisArthritis, Psoriatic

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Officials

Hakan Gürpınar
Humanis Saglık
STUDY DIRECTOR

Enrollment

36 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

February 15, 2023

Actual (reported)

You may not qualify if:

History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
Ingestion or Use of medication \[non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines)\] at any time from 14 days prior to dosing of period-I and Use of any prescribed systemic or topical medication from 30 days prior to dosing of period-I and any vaccine (including COVID-19 vaccine) within 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
Consumption of grapefruits or its products within a period of 72 hours prior to dosing of period-I.
Smokers or who have smoked within last 06 months prior to start of the study.
A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing of period-I.
The presence of clinically significant abnormal laboratory values during screening.
Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
History or presence of seizure or psychiatric disorder
A history of difficulty with donating blood.
Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication\*\*.
\*\* If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
Difficulty in swallowing tablet or oral solid dosage form
A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
+7 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Apremilast 30 mg Tablets

Otezla 30 mg film-coated tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Apremilast 30 mg Tablets

Otezla 30 mg film-coated tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations