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

Exclusion Criteria

• •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.
• •A positive test result for HIV antibody (1 \&/or 2).
• •An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to receiving the study drug in period I. In any such case subject selection will be at the discretion of the Principal Investigator.
• •Hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
• •Any condition which places the subject at unacceptable risk if he/she were to participate 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 bowel syndrome, Crohn's disease, etc.
• •The QTc interval more than 450 msec for male subjects and 460 msec for female subjects at the time of screening.
• •Nursing mothers (for female subjects).