A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets and Reference Product, Xatral® XL 10 mg, in Healthy Thai Male Volunteers under Fed and Fasting Conditions
- Conditions
- Healthy Thai Male Volunteers
- Registration Number
- TCTR20181115002
- Lead Sponsor
- International Bio Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Male
- Target Recruitment
- 42
1. Healthy Thai male subjects between the ages of 18 to 55 years.
2. Body mass index between 18.0 to 25.0 kg/m2.
3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
4. 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.
5. 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 alfuzosin or any of the other components of this product
2. History or evidence of clinically significant renal, hepatic, gastrointestinal (e.g. intestinal occlusion), hematological, endocrine (e.g. thyroid), pulmonary or respiratory (e.g. allergic rhinitis, asthma), cardiovascular (e.g. tachycardia), psychiatric, neurologic (e.g. convulsion) 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 or evidence of regular faintness, dizziness, headache or postural hypotension
4. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
5. History of problems with swallowing tablet
6. History of sensitivity to heparin or heparin-induced thrombocytopenia
7. Any condition possibly affecting drug absorption e.g. oral mucous membrane lesions, gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
8. History of preceding diarrhea or vomiting within 24 hours prior to admission in each period
9. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
10. 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 or 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 minutes each. The last measurement value should be used to determine the subject’s eligibility.
11. Investigation of vital signs shows pulse rate less than 60 or more than 100 beats per minute 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 minutes each. The last measurement value should be used to determine the subject’s eligibility.
12. 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.
13. Investigation with blood sample shows positive test for HBsAg.
14. Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
15. Have renal creatinine clearance (CLcr) ≤ 30 mL/min based on serum creatinine results at the screening laboratory test
16. History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
17. 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
18. History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days p
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug concentration 0,0.5,1,2,3,4,5,6, 7,8,9,10,11,12,13,14,16,24,36,48 h Pharmacokinetic evaluation
- Secondary Outcome Measures
Name Time Method Safety evaluation 0-48 hr Adverse events e.g. dry mouth, headache, fatigue and somnolence