A Bioequivalence Study of Two Formulations of 50-mg Mirabegron Prolonged Release Tablets in Healthy Thai Volunteers under Fed Conditions
- Conditions
- Overactive bladder syndromeOveractive bladder syndrome OAB
- Registration Number
- TCTR20220223006
- Lead Sponsor
- ovartis (Thailand) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 44
1. Thai Male/Female body mass index (BMI) = 18.0-30.0 kg/m2, inclusive. 2. Must be in good health as determined by medical history, vital signs (blood pressure (systolic blood pressure not lower than 90 or not over 129 mmHg, diastolic blood pressure not lower than 60 or not over 79 mmHg), body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians 3. Screening electrocardiogram (ECG) without clinically significant abnormalities 4. Screening visit laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasting blood sugar (FBS), blood urea nitrogen (BUN), creatinine (Cr) and liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and alkaline phosphatase (ALP)) must be within the normal range or showing no clinically significant abnormalities in the opinion of Principal Investigator or designated physicians. 5. Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of Principal Investigator or designated physicians. 6. Must have serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus antibody (anti-HIV) seronegative (for screening visit 1 only) 7. Female subjects must have beta-subunit of human chorionic gonadotropin in serum negative (for screening visit 1 only). 8. Female subject who is childbearing potential or male subject agrees to use an acceptable birth control method from visit 1 to the follow-up visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the follow-up visit. Hormonal contraceptives are not acceptable. 9.Female subject who is non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea))10. Female subjects must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing prior to dosing at period 1, period 2, period 3, and period 4 11. Non-smokers (never smoked or no smoking within the previous 1 year) 12. Refrain from using herbal medications, dietary supplements, vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of study drug (Day 1). Subjects must agree to refrain from these items until the last collection time-point of period 4. 13. Subjects must have ended any medications at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow up period. 14. Subject does not receive Coronavirus Disease-19 (COVID-19) vaccine within 14 days before screening visit and does not plan to receive COVID-19 vaccine until the follow-up period. 15. Subjects must refrain from drinking caffeine and alcohol for at least 72 hours prior to Day 1 and agree to continue their refraining throughout the last collection time-point of period 4. 16. Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedu
1 Known hypersensitivity to mirabegron or any other similar class of drugs or its components 2. Past medical history of renal and hepatic insufficiency 3. Subject has a history of any illness that, in the opinion of principal investigator or designated physicians, might confound the result of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements. 4. Have history of drug abuse (in the opinion of principal investigator or designated physicians, as judged by medical history) in the last 12 months 5. Have positive result of urine drug abuse testing 6. Alcohol abuse or excessive use (in the opinion of Principal Investigator or designated physicians, as judged by medical history) in the last 12 months 7. Have positive result of alcohol breathing test at screening visit or before dose administration at each period 8.Female subject is pregnant or breast feeding. 9. Difficulties fasting or consuming standard meals 10. Difficulties swallowing whole tablets 11. Donation or loss of whole blood 12.Participation in any investigation drug study within 1 month from screening (from the last follow-up visit to the screening visit)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mirabegron level in plasma pre-dose and at 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00, and 192.00 hours Pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, tmax of mirabegron
- Secondary Outcome Measures
Name Time Method /A N/A N/A