None listed
Conditions
Interventions
Intervention1: DanzitenTM (nilotinib) tablets 95 mg: Dose: 2 Tablets 95 mg. 190 mg
Frequency: Single dose, Three periods.
Route of administration: Oral
Duration of study: 33 days with washout perio
Sponsors
Azurity Pharmaceuticals, Inc. USA
Zenrise Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participants must fulfil all of the following criteria to be considered for inclusion into this study: 1. Healthy, adult, humans aged at least 18 to 45 years (both inclusive) of age. 2. Body mass index between 18.50 kg/m2 and 30.00 kg/m2 (both inclusive) and body weight 45 kgs or more. 3. Non-smokers and without a history of alcohol or drug abuse. 4. Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the check-in of Period-I. 5. Having normal 12-lead electrocardiogram (ECG) and chest X- Ray (PA view). 6. Able to communicate effectively. 7. Willing to give written informed consent and adhere to protocol requirements as evidenced by written informed consent approved by an Ethics Committee (EC). 8. Male trial participant with female partner of reproductive potential who is willing to follow approved birth control methods for the duration of the study and at least 14 days after nilotinib last dose as judged by the investigator(s). 9. Male trial participant who is willing NOT to donate sperm for duration of the study and at least 14 days after nilotinib last dose. 10. Female trial participant of child bearing potential, willing to follow an acceptable method of birth control for the duration of study and at least 14 days after nilotinib last dose, as judged by the investigator(s) or abstinence Or Is postmenopausal for at least 1 year Or Is surgically sterile
Exclusion criteria
Exclusion criteria: Participants will not be eligible for study participation if any of the following criteria is met: 1. History of contraindications or hypersensitivity to Nilotinib or any of the excipients in the formulation. 2. History or presence of Clostridium difficile associated diarrhea. 3. Presence of urinary retention, gastric retention and uncontrolled narrow-angle glaucoma 4. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or any other medical condition or diseases according to the opinion of the physician. 5. Having Creatinine Clearance (CrCl) less than 90 mL/min 6. Who have abnormal liver function tests or blood counts. 7. Who have abnormal serum electrolytes. 8. Long QT syndrome, or a history of cardiac disease. 9. Having history of cholestatic jaundice/hepatic dysfunction. 10. Having history of exacerbation of symptoms of myasthenia gravis. 11. Systolic blood pressure less than 100 mmHg or more than 140 mmHg. 12. Diastolic blood pressure less than 60 mmHg or more than 90 mmHg. 13. Pulse rate less than 60 beats/minute or more than 100 beats/minute. 14. QT value greater than 440 milliseconds (ms). 15. Usage of any prescribed medication, herbal medications and OTC medicinal products within 14 days prior to period-I check in. 16. Usage of pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days prior to period-I check in. 17. Tested positive for either VDRL, HIV (1 & 2) antibodies, HbsAg (Hepatitis B surface antigen), HCV antibodies. 18. Tested positive for urine or breath alcohol test and urine screen for drugs of abuse [(Cannabinoids (Marijuana / Tetra Hydro Cannabinoids-THC), Cocaine, opiates, amphetamine, barbiturates, benzodiazepines] at the time of check-in. 19. Who are on therapy of strong CYP3A4 inhibitors (e.g. Ketoconazole, Clarithromycin, Ritonavir, Voriconazole etc.) or inducers (e.g. Rifampin, Avasimibe, St. John s wort, Phenytoin, Carbamazepine etc.) Proton pump inhibitors, and medications known to prolong QT/QTC interval. 20. Male trial participant with female partner of reproductive potential NOT willing to use effective contraception methods for the duration of the study and willing to donate sperm for duration of the study at least 14 days after nilotinib last dose as judged by the investigator(s) 21. Female trial participant of child bearing potential, NOT willing to follow an acceptable method of birth control for the duration of the study and at least 14 days after nilotinib last dose as judged by the investigator(s), Or Pregnant or lactating Or Amenorrhea during past 6 months. Or Unprotected sex with any non-sterile male partner prior to drug administration, for the duration of the study and at least 14 days after nilotinib last dose. Or Tested positive for serum beta hCG test at the time of check in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the rate and extent of absorption of DanzitenTM (nilotinib) tablets 95 mg (Dose: 2 Tablets 95 mg. 190 mg) of Azurity Pharmaceuticals, Inc., USA under fed condition and Tasigna (nilotinib) hard capsules 200 mg (Dose: 2 Capsules 200 mg. 400 mg) of Novartis Europharma Limited, Ireland under modified fasting condition with different fat content in healthy, adult, human trial participants.Timepoint: Pre-dose to 96.000 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of DanzitenTM (nilotinib) tablets 95 mg under fed condition and Tasigna (nilotinib) hard capsules 200 mg (Dose: 2 Capsules 200 mg. 400 mg) under modified fasting condition with different fat content in healthy, adult, human trial participants.Timepoint: Pre-dose to 96.000 hours post dose | — |
Countries
India
Contacts
Public ContactMr S Sri Harsha
ZenRise Clinical Research Private Limited
Outcome results
None listed