Comparative Randomized, Single Dose, Two-Way Crossover, Open-LabelStudy to Determine the Bioequivalence of Carvedilol 12.5 mg TabletsFormulations, Dilatrend and Carvolol (12.5 mg), after Oral Administration toHealthy Thai Volunteers under Fasti

The Government Pharmaceutical Organization0 sites62 target enrollmentDecember 22, 2016

Overview

No summary available.

Registry

who.int

Start Date

December 22, 2016

End Date

March 30, 2017

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•a)Be healthy male or female subjects between 18\-55 years of age (both inclusive).
•b)Have a Body Mass Index (BMI) between 18\.0\-25\.0 (both inclusive), 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.
•g)In case of female subjects:
•â€¢Females of child\-bearing potential agree to use an acceptable method of birth control for entire duration of the study as judge by the investigator(s):
•i.Non hormonal intrauterine device in place of at least 3 months prior to the start of the study and remaining in place during the study period, or
•ii.Barrier methods containing or used in conjunction with a spermicidal agent, such as condoms, foams, jellies, diaphragm, etc., or

•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.