» Advanced search
Only first 10,000 results will be saved in the file.
No item is selected. Use checkboxes to select search results.
Displaying 1-1 of 1 results.
 
{{ selectedCountPage }} items selected on this page, {{ selectedCountPage }} item selected on this page, {{ selectedCountTotal }} item in total {{ selectedCountTotal }} items in total
Study aim: Examining the bioequivalency of domestically produced Mirabegron Extended-Release tablets formulations with brand name ®Betmiga Design: A cross over, not blinded, randomized, bioequivalence clinical trial on 24 healthy volunteers. Settings and conduct: Study place: Drug Applied Research Center affiliated to Tabriz University of Medical Science. The number of 24 volunteers in the age range of 18-55 years and the Body Mass Index range of 18-30, who are voluntarily selected through public notification. One extended-release tablet is taken fasting and blood is taken at 15 time points. Two weeks later, the process is repeated for the brand medicine. Participants/Inclusion and exclusion criteria: Inclusion criteria: The weight range of 60-100 kg; being a non-smoker; being healthy in terms of physical examination, ECG, and the laboratory tests; Volunteers who have agreed to an informed consent form. Exclusion criteria: History of allergic or adverse reaction to Mirabegron or any similar product; blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg; Individuals who have donated whole blood during the previous 2 months of the study or donated blood components within 2 weeks before taking the first dose of the drug. Intervention groups: Intervention group 1: Mirabegron Extended-Release tablets manufactured by Faran Shimi Pharmaceutical Company is the test product. Intervention group 2: Betmiga® tablets manufactured by Astellas Company is the reference product. In each period, 12 of 24 subjects will be given single dose of this product and for up to 72 hours, 3 ml of blood will be collected from the volunteer at 15 time points each time. After the washout period (Two weeks), the volunteers are placed in the opposite group Main outcome variables: Plasma concentration of the drug
IRCTID: IRCT20130313012810N159
  1. Comparative bioequivalence study of Mirabegron 50 mg Extended-Release Tablets manufactured by Darou Andishe Novin Shargh Pharmaceutical Co. vs. Betmiga® tablets manufactured by Astellas in healthy volunteers
  2. Comparative bioequivalence study of the Mirabegron 25 mg Extended-Release Tablets manufactured by Anousha Pharmaceutical Company
  3. Comparative bioequivalence study of the Mirabegron 50 mg Extended-Release Tablets manufactured by Anousha Pharmaceutical Company
  4. A Bioequivalence Study of Mirabegron 50 mg Extended Release (ER) Tablet: Comparison of the Test Drug Manufactured by Actoverco Pharmaceutical Company with the Reference Drug, Betmiga 50 mg
  5. Bioequivalence study of Mirabegron 50 mg slow-release tablets from Teb Mofid Nikan Pharmaceutical Company compared to Mirabegron 50 mg slow-release tablets from Astellas, UK, on ​​healthy volunteers
  6. Comparative bioequivalence study of the extended release tamsulosin hydrochloride 0.4 mg/ Immediate release solifenacin 6 mg, tablet manufactured by Anousha Pharmaceutical Company VS. Vesomni® tablet manufactured by Astellas
  7. Comparative bioequivalence study of the Dexlansoprazole 60 mg Delayed-release Tablets manufactured by Darman Yab Darou Pharmaceutical Company vs. Dexilant® Tablets manufactured by Takeda Pharma Pharmaceutical Company in healthy volunteers
  8. Bioequivalence study of Naproxen 750mg Sustained Release tablets manufactured by Darman Yab Darou Pharmaceutical Company vs. Apo-Naproxen SR® tablets manufactured by Apotex Inc Company in healthy volunteers
  9. Bioequivalence study of Enzalutamide 40mg Soft gelatin capsules manufactured by Anousha Pharmaceutical Company vs. Xtandi ® Soft gelatin capsules manufactured by Astellas pharma Pharmaceutical Company in healthy volunteers
  10. Bioequivalence study of of the Doxycycline Hyclate 100 mg Delayed- Release Capsules manufactured by Behsazan Pazhohan Omid Arya Pharmaceutical Company vs. Doryx ® tablets manufactured by Mayne Pharma Company in healthy volunteer
Loading...