An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Cross Over Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

0005-22

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

2023-02-15

2023-02-25

2023-04-25

Completed

Early phase I

36

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

2023-12-13