A Bioequivalence Study of Two Formulations of Mirabegron 50-mg Prolonged-release Tablets in Healthy Thai Subjects under Fasting Conditions
- Conditions
- Healthy VolunteersPharmacokineticsMirabegronBioequivalence
- Registration Number
- TCTR20230713003
- Lead Sponsor
- ovartis (Thailand) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 72
1. Thai Male/Female must be 18-55 years of age, 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 and not over 139 mmHg, diastolic blood pressure not lower than 60 and not over 89 mmHg), body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of Principal/Clinical 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/Clinical Investigator or designated physicians.
5. Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians
6. Must have serum hepatitis B surface antigen (HBsAg), anti-HCV (hepatitis C virus antibody) and anti-HIV (human immunodeficiency virus antibody) negative.
7. Female subject must have serum beta-subunit of human chorionic gonadotropin negative.
8. Female subject of 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 of non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea))
10. Female subject 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 each period.
11.Non-smoker (never smoked or no smoking within the previous 1 year)
12.Refrain from using herbal medications, cannabis containing products, dietary supplements (e.g., St. Johns Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of investigational product (Day 1). Subjects must agree to refrain from these items until the last collection time-point of Period 4.
13. Subject must have ended any systemic medications or any medications that have any impact on gastrointestinal system at least 30 days prior to Day 1 or at least 5 times of elimination half-life prior to Day 1 and agree to continue their refraining throughout the Follow-up Visit.
14.Subject does not receive Coronavirus Disease-19 (COVID-19) vaccine within 14 days before Screening Visit 1 and does not plan to receive COVID-19 vaccine until the Follow-up Visit.
15.Subject 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
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/Clinical Investigator or designated physicians, might confound the result of the study or pose an additional risk in administering investigational product 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/Clinical Investigator or designated physicians, as judged by medical history) in the last 12 months
5. Have positive result of urine drug abuse testing on opioids (morphine (Mor), methadone (MTD)), cannabinoids (tetrahydrocannabinol (THC)), methamphetamine (Meth), cocaine (Coc) or methylenedioxy-methamphetamine (MDMA) at each screening visit or before dose administration at each period.
6. Alcohol abuse or excessive use (in the opinion of Principal/Clinical Investigator or designated physicians, as judged by medical history) in the last 12 months
7. Have positive result of alcohol breathing test at each 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:
a. More than or equal to 50 mL and less than or equal to 499 mL within 30 days prior to Day 1
b. More than or equal to 500 mL within 56 days prior to Day 1
12. Participation in any investigational drug study within 30 days from Screening Visit 1 (from the last Follow-up Visit to the Screening Visit 1). Subject who participates in COVID-19 vaccine trial that does not have any intervention during the course of this study (from the expected enrollment date to the expected Follow-up Visit) can be included in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum plasma concentration Pre-dose and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00, and 192.00 hours post-dose Mirabegron plasma concentration,Area under the concentration-time profile to the last quantifiable concentration Pre-dose and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00, and 192.00 hours post-dose Area under the mirabegron plasma concentration-time curve from pre-dose to the last quantifiable concentration (192.00 hours),Area under the concentration-time profile following administration of a single dose, extrapolated to infinite time Pre-dose and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00, and 192.00 hours post-dose Area under the mirabegron plasma concentration-time curve from pre-dose to extrapolated infinite time
- Secondary Outcome Measures
Name Time Method /A N/A N/A