Open Label, Randomized, Two-way Crossover, Two-sequence, Two-period, Two-treatment Bioequivalence Study of 20 mg of Tadalafil Film-coated Tablet Preparations in Healthy Thai Male Volunteers
- Conditions
- Bioequivalence study,healthy Thai malesTadalafil,Bioequivalence,Thai,Healthy
- Registration Number
- TCTR20170112003
- Lead Sponsor
- International Bio Service Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated (Halted Prematurely)
- Sex
- Male
- Target Recruitment
- 26
1Healthy Thai male subjects between the ages of 18 to 55 years.
2Body mass index between 18.0 to 25.0 kg/m2.
3Normal 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.
4Male 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.
5Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
1History of allergic reaction or hypersensitivity to tadalafil, sildenafil, vardenafil or other selective inhibitors of PDE-5 or any of the excipients of this product
2History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine (e.g. thyroid), pulmonary or respiratory (e.g. asthma), psychiatric, neurologic (e.g. depression, insomnia), or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
3History or evidence of cardiovascular disease e.g. heart failure, stroke, myocardial infarction, unstable angina, arrhythmias, hypotention or hypertention
4History or evidence of vision disorder or genetic vision disorder e.g. decreased vision or loss of vision etc.
5History or evidence of anatomical deformation of the penis (e.g. angulation) or priapism
6History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
7History of problems with swallowing tablet
8History of sensitivity to heparin or heparin-induced thrombocytopenia
9Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
10History of preceding diarrhea within 24 hrs prior to admission in each period
11Have 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 minutes each. The last measurement value should be used to determine the subject’s eligibility.
12Investigation 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.
13History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine).
1412-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.
15Investigation with blood sample shows positive test for HBsAg.
16Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
17Have renal creatinine clearance (CrCl) ≤80 mL/min based on serum creatinine results at the screening laboratory test
18History 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
19History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admiss
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tadalafil plasma concentrations 0,0.16,0.33,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,10,12,24,36,48,72 hrs post-dose Cmax and Truncated AUC0-72
- Secondary Outcome Measures
Name Time Method Tadalafil plasma concentrations 0,0.16,0.33,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,10,12,24,36,48,72 hrs post-dose Tmax, t1/2 and lamda Z