An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Ivacaftor film coated tablets 150 mg of Sun Pharmaceutical Industries Ltd, India with Kalydeco (Ivacaftor) 150 mg film-coated tablets, Marketing Authorisation Holder: Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland, in healthy adult, human subjects under fed condition.

Trial details

Who runs it

Sun Pharmaceutical Industries Limited

Trial code

EU 2023-508115-23-00

Record updated

2024. február 12.

Original description

To assess the bioequivalence of a single-oral dose of the test product, Ivacaftor film coated tablets 150 mg of Sun Pharmaceutical Industries Ltd, India with Kalydeco (Ivacaftor) 150 mg film-coated tablets, Marketing Authorisation Holder: Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland, in healthy, adult, human subjects under fed condition.Read full original descriptionShow less

To assess the bioequivalence of a single-oral dose of the test product, Ivacaftor film coated tablets 150 mg of Sun Pharmaceutical Industries Ltd, India with Kalydeco (Ivacaftor) 150 mg film-coated tablets, Marketing Authorisation Holder: Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland, in healthy, adult, human subjects under fed condition.

Inclusion: Healthy male or female volunteer with age between 18-45 years, inclusive; Non-vegetarian diet habit; Body mass index (BMI) in the range of 18.50 kg/m2 to 29.00 kg/m2; Voluntarily given written informed consent to participate in this study; Screening procedures performed within 28 days prior to the first dosing in the study; Non-pregnant, non-lactating female willing to practice during the study period a method of birth control considered to be effective (i.e. condom, diaphragm, non-hormonal intrauterine device or abstinence) or surgically sterile or postmenopausal for at least 2 years.

Exclusion: Use of any pharmacological agent or dietary product known to induce the study drug metabolism within 28 days prior to the dosing day of this study or any pharmacological agent or dietary product known to inhibit the study drug metabolism within 14 days prior to the dosing day of this study; Use any Investigational Medicinal Product in a clinical trial within 12 weeks prior to the dosing day of this study; Donation or significant blood loss (400 mL or more) within 12 weeks prior to the dosing day of the study; Positive urine test for drugs of abuse at screening; Unprotected sexual intercourse (for females of childbearing potential) with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration; History of allergic reactions to ivacaftor or to any of the excipients; History of drug dependence or alcohol intake on a habitual basis of more than 2 units of alcohol per day (1 unit alcohol equivalent to 500 mL beer; 200 mL wine; 50 mL distilled drinks); History of hypertension/hypotension or presence of persistent values measured in sitting position for systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg or for systolic blood pressure <90 mmHg and diastolic blood pressure <60 mmHg; History or presence of clinically significant gastrointestinal, hepatic, renal disease or any other condition known to interfere with the absorption, distribution, metabolism and excretion of the study drug; Positive for HIV 1 or 2, Hepatic B or C viruses markers or syphilis infection; History of any psychiatric illness; Positive urine or serum pregnancy test at screening; Clinically significant abnormalities in the laboratory results, as judged by the investigator; History or presence of clinically significant cardiovascular, respiratory, neurological, reproductive, musculoskeletal, lymphatic, hematological disease, diabetes/impaired glucose tolerance, systemic disorders (immunological and connective tissue) or any other disorder that in the opinion of the investigator may jeopardize the volunteer’s safety or influence the results of the study; Clinical important abnormalities in rhythm, conduction or morphology of the ECG that may interfere with the volunteer’s safety; Regular smokers who smoke more than 5 cigarettes daily.

EU CTIS 2023-508115-23-00