The study is conducted in healthy Thai human volunteers to treatment Schizophrenia Bioequivalence Aripiprazole Orally Disintegrating Tablets 10 mg
Conditions
Interventions
The new generic products which were recently developed. Volunteer subject will be recommended to wet the mouth by gargling and swallowing 20 mL of drinking water directly before applying Aripiprazole
Experimental Drug,Active Comparator Drug
Aripiprazole Orally Disintegrating Tablets 10 mg,Abilify Discmelt
Sponsors
Bio-innova Co., Ltd.
Eligibility
Sex/Gender
All
Age
30 Years to 55 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy Thai subjects are between 30 to 55 years of age. 3. The Body Mass Index (BMI) ranges from 18.5 to 30.0 kg/m2. 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to collect approximately 7 mL of blood for monitoring subjects safety during re-screening and after the completion of the study. 5. Negative urine pregnancy test and no breast-feeding (for female subjects). 6. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. History or evidence of allergy or hypersensitivity to Aripiprazole or any related drugs or any of the excipients of this product. 2. Subject with B.P. is Systolic B.P < 90, >=140 mm/Hg, Diastolic B.P < 60, >=90 mm/Hg, pulse rate > 100, < 50 beats per minute. 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 or HIV. 7. 12-lead EKG demonstrating QTc >450 msec, a QRSD >=120 msec10 or with an abnormality considered clinically significant at Screening. 8. History or presence of Cardiovascular, respiratory, gastrointestinal ,genitourinary, psychiatric ,neurological disease, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension 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 seizures or with conditions that lower the seizure threshold, e.g., Alzheimers dementia, severe head trauma. 12. History of psychiatric disorder, suicidal thoughts, behavior or suicide attempts. 13. Prior personal or family history of dystonic reactions to medications. 14. 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. 15. 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. 16. 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. 17. History of pomelo or grapefruit 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. 18. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids) or positive breath alcohol test result. 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 and until the completion of each period of the study. 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. (* Depend on d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Aripiprazole level pre-dose (0.0 hour) and at 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0 and 72.0 hours Maximum plasma concentration, area under the plasma concentration curve from dosing to last observed concentration at time t, area under the plasma concentration curve extrapolated to infinite time | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign (Systolic BP, Diastolic BP, Pulse) pre-dose (siting and supine position), at approximately 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0, 60.0 and 72.0 hours post-dose (supine position) Automatic blood pressure (Volunteer, Once),EKG at 3.0 - 5.0 hours after dosing and at 8.0 - 12.0 hours after dosing 12-lead EKG, Assessment of suicidal thought at check-in, approximately 4.0, 8.0, 12.0, 24.0, 36.0, 48.0, 60.0 and 72.0 hours post-dose Questionnaire | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed