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

Inclusion Criteria:

• 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 asweight in kg/height in m2.
• Not having significant diseases or clinically significant abnormal findings duringscreening, medical history, clinical examination, laboratory evaluations, 12 lead ECG,and chest X-ray recordings (P/A view).
• Able to understand and comply with the study procedures, in the opinion of theinvestigator.
• Able to give voluntary written informed consent for participation in the trial.
• In case of female subjects: Surgically sterilized at least 6 months prior to study participation. Or If of childbearing potential is willing to use a suitable and effective double barrier contraceptivemethod or intra uterine device during the study. And Serum pregnancy test must be negative.

Exclusion Criteria:

• History or presence of any disease or condition which might compromise thehaemopoietic, 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 14days prior to dosing of period-I and Use of any prescribed systemic or topicalmedication from 30 days prior to dosing of period-I and any vaccine (includingCOVID-19 vaccine) within 14 days prior to dosing of period-I. In any such case subjectselection will be at the discretion of the Principal Investigator.
• Any history or presence of asthma (including aspirin induced asthma) or nasal polyp orNSAIDs induced urticaria.
• Consumption of grapefruits or its products within a period of 72 hours prior to dosingof 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. alcoholconsumption of more than 14 standard drinks per week for men and more than 7 standarddrinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL ofwine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) orconsumption of alcohol or alcoholic products within 48 hours prior to dosing ofperiod-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 prestudy 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 firstdose of study medication.
• Receipt of an investigational medicinal product or participation in a drug researchstudy 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 noblood loss except safety lab testing, subject can be included considering 10half-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 HCVantibodies.
• A positive test result for HIV antibody (1 &/or 2).
• An unusual diet, for whatever reason (for example, fasting, high potassium orlow-sodium), for four weeks prior to receiving the study drug in period I. In any suchcase subject selection will be at the discretion of the Principal Investigator.
• Hereditary problems of galactose intolerance, total lactase deficiency orglucose-galactose malabsorption.
• Any condition which places the subject at unacceptable risk if he/she were toparticipate in the study, or confounds the ability to interpret data from the study.
• Any surgical or medical condition possibly affecting drug absorption, distribution,metabolism and excretion, eg, bariatric procedure, colon resection, irritable bowelsyndrome, Crohn's disease, etc.
• The QTc interval more than 450 msec for male subjects and 460 msec for female subjectsat the time of screening.
• Nursing mothers (for female subjects).