A Bioequivalence study of a randomized open-label single dose two-way crossover design with two-period two-treatment and two-sequence of Aripiprazole 10 mg Orally Disintegrating Tablets relative to Abilify Discmelt (Aripiprazole) Orally Disintegrating Tablets in healthy Thai under fasting
- Conditions
- Healthy subjectsBioequivalence Aripiprazole 10 mg Orally Disintegrating Tablets
- Registration Number
- TCTR20230503001
- Lead Sponsor
- Bio-innova Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 30
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 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 before participating period II and after the completion of the study.
5.Negative urine pregnancy test for women and no breast-feeding.
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.
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
7.12-lead EKG demonstrating QTc >450 msec, a QRSD >120 msec or with an abnormality considered clinically significant at Screening. If QTc exceeds 450 msec, or QRSD exceeds 120 msec, the EKG should be repeated two more times and the average of the three values should be used to determine the subject eligibility.
8.History or evidence of heart, 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., Alzheimer, 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).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC0-72 0.0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0 and 72.0 hours post-dose Pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method Safety; Adverse events 0.0, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 12.0, 24.0, 48.0, 60.0 and 72.0 hours for vital sign, at 3.0-5.0 hours and at 8.0-12.0 hours for EKG and 0.0,4.0,8.0,12.0,24.0,48.0,72.0 for suicidal Safety monitoring, vital sign, EKG, assessment of suicidal thought