Healthy Thai Volunteers Carvedilol Bioequivalence study Healthy Volunteers Thai
Conditions
Interventions
VECALOL 12.5 (Carvedilol 12.5 MG)
Dose: 12.5 mg
Duration: Single dose
Mode of administration: Orally,DILATREND (Carvedilol 12.5 MG)
Dose: 12.5 mg
Duration: Single dose
Mode of administration: Orally
Experimental Drug,Active Comparator Drug
VECALOL 12.5 (Carvedilol 12.5 MG),DILATREND (Carvedilol 12.5 MG)
Sponsors
Millimed Co., Ltd. (Branch)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai male or female subjects between the ages of 18 to 55 years. 2. Body mass index between 18.0 to 30.0 kg/m2 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding. 5. Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1: Postmenopausal for at least 1 year or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months 6. Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2. 7. Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction or hypersensitivity to carvedilol or any component of the product 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric, neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 4. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 5. History or evidence of congestive heart failure, ischaemic heart disease,myocardial infarction or arrhythmia 6. History or evidence of diabetes mellitus or hypoglycemia 7. History or evidence of chronic obstructive pulmonary disease or asthma 8. History or evidence of bradycardia 9. Have pulse rate of less than 50 bpm 10. History or evidence of shock including cardiogenic shock or hypovolemic shock
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 34.00 and 48.00 hrs PK and Statistic analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 34.00 and 48.00 ADR report | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
international Bio Service Co., Ltd.
Outcome results
None listed