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
- Conditions
- Healthy male volunteers
- Registration Number
- TCTR20170821003
- Lead Sponsor
- The Government Pharmaceutical Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Male
- Target Recruitment
- 34
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.
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.
k)Consumption of xanthine containing products (i.e. tea, coffee, chocolates or cola drinks) more than 3 cups/day or consuming these products within 24 hours prior to dosing.
l)Heavy smoking (> 10 cigarettes/day).
m)Moderate smoking (< 10 cigarettes/day) and consumption of tobacco containing products, which cannot stop smoking or consuming 24 hours prior to dosing and for entire duration of the study.
n)Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
o)Consumption of any medication (including over-the-counter products, herbal remedies), or vitamins, or dietary supplements at any time within 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator.
p)Any food allergy, intolerance, restriction or special diet that, in the opinion of Principal Investigator, could contraindicate the volunteer’s participation in the study.
q)Difficulty in swallowing solid dosage forms like tablets or capsules.
r)Intolerance to venipuncture.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90%CI of pharmacokinetic parameters derived from drug plasma concentration-time profile 24 blood sampling time points from 0 - 96 hours post dose Bioanalysis and pharmacokinetic data analysis
- Secondary Outcome Measures
Name Time Method Adverse events/Severe adverse events Pre-dose and at 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hrs post dose Physical and biochemical examination eg. vital signs; blood pressure, respiratory rate, pulse rate