Open Label, Randomized, Two-way Crossover, Two-sequence, Two-period, Two-treatment Bioequivalence Study of 5 mg Olanzapine Orodispersible Tablet Preparations in Healthy Thai Volunteers under Fasting Conditions-Pilot Study
- Conditions
- Healthy volunteers
- Registration Number
- TCTR20170306002
- Lead Sponsor
- International Bio Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 10
1.Healthy Thai male/female subjects between the ages of 18 to 55 years
2.Non-smoker and/or non-consumer of nicotine containing products
3.Body mass index between 18.0 to 25.0 kg/m2
4.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening
5.Non-pregnant woman (negative pregnancy test) and not currently breast feeding
6.Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to admission in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission in Period 1:
ï‚· Postmenopausal for at least 1 year or
ï‚· Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
7.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study
8.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
1.History of allergic reaction or hypersensitivity to olanzapine or any of the component of the formulation
2.History or evidence of clinically significant renal, hepatic, diabetes mellitus, hyperglycemia, gastrointestinal, hematological, endocrine (e.g. thyroid), pulmonary or respiratory (e.g. allergic rhinitis, asthma), cardiovascular (e.g. arrhythmia or hypotention), psychiatric disorder (e.g. depression), neurologic (e.g. CNS disorder, seizures or Parkinson’ disease), cerebrovascular, narrow-angle glaucoma or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at time of dosing or chronic urticarial) or any significant ongoing chronic medical illness
3.History of sensitivity to heparin or heparin-induced thrombocytopenia
4.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
5.History of preceding diarrhea within 24 hrs prior to admission in each period
6.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
7.Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and the day of admission. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subject’s eligibility
8.Investigation of vital signs shows pulse rate less than 60 or more than 100 beats per min on screening day or on the day of admission. If abnormal pulse rate detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subject’s eligibility
9.12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject’s eligibility
10.Investigation with blood sample shows positive test for HBsAg
11.Investigation with blood sample shows level of potassium less than 3.4 or more than 4.5 mmol/L
12.Investigation with blood sample shows level of magnesium less than 1.6 or more than 2.4 mg/dL
13.Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
14.History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
15.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
16.Consumption or drinking of grapefruit juice or orange or its supplement/containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
17.Use of prescription or no
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic evaluation 0,0.5,1,1.5,2,2.5,3,4,5,6,7,8,10,12,24,36,48,72 hr Drug concentration
- Secondary Outcome Measures
Name Time Method Safety evaluation 0-72 hr Adverse events