Healthy subjects Bioequivalence Lurasidone Hydrochloride Tablet 40 mg
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of Lurasidone Hydrochloride Tablet 40 mg of either test or reference with 250 mL of drinking water.,The mar
Experimental Drug,Active Comparator Drug
Lurasidone Hydrochloride 40 mg,Latuda 40 mg
Sponsors
Bio-innova Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai subjects are between 18 to 55 years of age. 2. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2. 3. Healthy, no history of evidence of chronic disease or severe disorder. 4. No history of usually smoking (more than 10 cigarettes per day within past 1 year). 5. No history of alcoholism (more than 2 years). 6. Negative pregnancy test for women and no breast-feeding.
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Lurasidone Hydrochloride or any related drugs or any of the excipients of this product. 2. Subject with B.P. is Systolic B.P < 100, >= 140 mm/Hg, Diastolic B.P < 70, >= 90 mm/Hg or pulse rate > 100 beats per minute. For study periods, BP evaluation criteria for AE after drug administration will be < 90, >= 140 mm/Hg, Diastolic B.P < 60, >= 90 mm/Hg. 3. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).* 4. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).* 5. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).* 6. Positive of hepatitis B or C virus. 7. Have more than one abnormal EKG, which is considered as clinically significant. * 8. History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, cerebrovascular disease, dyslipidemia, immune disease or glaucoma. 9. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 10. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 11. History of psychiatric disorder, depression or suicidal attempt. 12. History of seizures or with conditions that lower the seizure threshold, e.g., Alzheimer, dementia, severe head trauma. 13. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 14. History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of each period of the study. 15. High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 16. History of grapefruit or pomelo or grapefruit products consumption and cannot stop at least 7 days before the study drug administration and until the completion of each period of the study. 17. History of St. John s Wort products consumption and cannot stop at least 28 days before the study drug administration and until the completion of the study. 18. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids). 19. Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to receiving the first dose of study medication. 20. History of difficulty in accessibility of veins in left and right arm. 21. Blood donation (one unit or 450 mL) within the past 3 months before the study. 22. Participation in any clinical study within the past 3 months before the study. 23. Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax AUC0-t and AUC0-inf pre-dose (0.00), 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00, 48.00 and 72.00 hours Pharmacokinetics parameter | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; Adverse events 1.0, 2.0, 3.0, 4.0, 6.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hours for vital sign and 3.0, 12.0, 24.0, 48.0 and 72.0 hours for suicidal thought or behavior Safety monitoring, vital sign, suicidal thought or behavior | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co.,Ltd
Outcome results
None listed