bioequivalence study of two products of apremilast 30 mg tablets in healthy, adult, human subjects

Conditions: Psoriasis and Psoriatic Arthritis

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


Eligibility criteria:
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 as weight in kg/height in m2. * not having significant diseases or clinically significant abnormal findings during screening, 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 the investigator. * 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 child bearing potential is willing to use a suitable and effective double barrier contraceptive method 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 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).