Comparative Randomized, Single Dose, Two-Way Crossover, Open-Label Study to Determine the Bioequivalence of Carvedilol 6.25 mg Tablets Formulations, Dilatrend and Carvolol (6.25 mg), after Oral Administration to Healthy Thai Volunteers under Fasting Conditions
- Conditions
- Healthy male and female volunteersCarvedilolBioequivalence
- Registration Number
- TCTR20170119001
- Lead Sponsor
- The Government Pharmaceutical Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 62
a)Any history of hypersensitivity to carvedilol 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, urticaria or other allergic type reactions after taking any medication.
e)Orthostatic hypotension.
f)Sitting blood pressure less than 110/70 mmHg, or pulse rate less than 60 or more than 100 beats per minute.
g)A positive hepatitis screen including HBsAg and/or anti-HCV.
h)A positive test result for anti-HIV.
i)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.
j)History of difficulty with donating blood or difficulty in accessibility of veins.
k)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.
l)Consumption of grapefruit, pomelo, orange, or any products containing these fruits within 48 hours prior to dosing.
m)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.
n)Heavy smoking (> 10 cigarettes/day).
o)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.
p)Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
q)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.
r)Any food allergy, intolerance, restriction or special diet that, in the opinion of Principal Investigator, could contraindicate the volunteer’s participation in the study.
s)Difficulty in swallowing solids dosage forms like tablets or capsules.
t)Intolerance to venipuncture.
a)Any history of hypersensitivity to carvedilol 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, urticaria or other allergic type reactions after taking any medication.
e)Orthostatic hypotension.
f)Sitting blood pressure less than 110/70 mmHg, or pulse rate less than 60 or more than 100 beats per minute.
g)A positive hepatitis screen including HBsAg and/or anti-HCV.
h)A positive test result for anti-HIV.
i)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.
j)History of difficulty with donating blood or difficulty in accessibility of veins.
k)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.
l)Consumption of grapefruit, pomelo, orange, or any products containing these fruits within 48 hours prior to dosing.
m)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.
n)Heavy smoking (> 10 cigarettes/day).
o)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.
p)Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
q)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.
r)Any food allergy, intolerance, restriction or special diet that, in the opinion of Principal Investigator, could contraindicate the volunteer’s participation in the study.
s)Difficulty in swallowing solids dosage forms like tablets or capsules.
t)Intolerance to venipuncture.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90%CI of pharmacokinetic parameters 25 Bioanalysis and pharmacokinetic data analysis
- Secondary Outcome Measures
Name Time Method Side effects and Severe adverse events During the study after dosing Severity degree and Number of events