TCTR20170821003
Not yet recruiting
未知
Comparative Randomized, Single Dose, Two-Way Crossover, Open-Label Study to Determine the Bioequivalence of Tadalafil 20 mg Tablets Formulations, Cialis and TADAFIL, after Oral Administration to Healthy Thai Volunteers under Fasting Conditions
ConditionsHealthy male volunteers
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Healthy male volunteers
- Sponsor
- The Government Pharmaceutical Organization
- Enrollment
- 34
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a)Be healthy male subjects between 18 \- 55 years of age.
- •b)Have a Body Mass Index (BMI) between 18\.0 \- 25\.0 calculated as weight in kg/height in m2\.
- •c)Have no evidence of underlying disease or clinically significant abnormal finding during screening, medical history examination, physical examination.
- •d)Have no abnormal finding during laboratory examination such as complete blood count, hematocrit, hemoglobin, fasting blood sugar, blood urea nitrogen (BUN), serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, total protein, albumin, HBsAg, Anti\-HCV, Anti\-HIV, urine analysis, chest X\-ray and 12\-Lead ECG recording or judged by physician as clinically insignificant or acceptable.
- •e)Able to understand and comply with the study procedures, in the opinion of the Principal Investigator.
- •f)Able to give voluntary written inform consent for participation in the trial.
Exclusion Criteria
- •a)Any history of hypersensitivity to tadalafil or any of its excipients.
- •b)A recent history or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
- •c)Clinically significant illness within 4 weeks before the start of the study.
- •d)Any history of bronchospasm, asthma, urticarial, or other allergic type reactions after taking any medication.
- •e)A positive hepatitis screen including HBsAg and/or anti\-HCV.
- •f)A positive test result for anti\-HIV.
- •g)Has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood (1 unit or 350 mL) in the preceding 90 days prior to the start of the study.
- •h)History of difficulty with donating blood or difficulty in accessibility of veins.
- •i)A recent history of harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy, etc.), or consumption of alcohol or alcoholic product within 48 hours prior to dosing, or testing positive in pre\-study breath test for alcohol consumption.
- •j)Consumption of grapefruit, pomelo, orange, or any products containing these fruits within 48 hours prior to dosing.
Outcomes
Primary Outcomes
Not specified
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