Bioequivalence Study in Healthy Thai Volunteers Ivabradine 7.5 mg Film-coated Tablet in Healthy Thai Volunteers under Fed conditions
Conditions
Interventions
Each tablet contains Ivabradine 7.5 mg.,Each tablet contains Ivabradine hydrochloride 8.085 mg (equivalence to 7.5 mg of Ivabradine), Coralan 7.5 mg, Reg. No. 1C 50/51(N), manufactured by Les Laborato
Experimental Drug,Active Comparator Drug
Test (T): Generic Ivabradine 7.5 mg film-coated tablet ,Reference (R): Ivabradine 7.5 mg film-coated tablet
Sponsors
International Bio Service Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai male/female subjects between the ages of 18 to 55 years. 2. Body mass index between 18.0 to 30.0 kg per square meter 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 (Clinical Investigator) 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 admission in Period 1. Injectable contraceptives e.g. Depo-Provera must be discontinued at least 6 months. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study. Female subjects of nonchildbearing potential must meet at least one of the following criteria prior to admission 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 ivabradine or related structure or any of the components of the product 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric, neurologic (e.g. seizures), allergic disease (including drug allergies, butexcluding 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 about administration of first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period. 5. History of abnormal visual e.g. blurred vision, diplopia, visual impairment 6. History or problems with swallowing tablets 7. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 8. History of sensitivity to heparin or heparin-induced thrombocytopenia 9. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 10. History of diarrhea or vomiting within 24 hours prior to check-in in each period 11. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 12. Investigation of vital signs shows pulse rate less than 60 or more than 100 beats per minute on screening day and on the day of admission. If abnormal pulse rate detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject is eligibility. 13. Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and check-in day. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subject is eligibility. 14. 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject is eligibility. 15. Investigation with blood sample shows positive test for HBsAg. 16. Abnormal liver function, >= 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 17. History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study. 18. History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.) 19. History or evidence of alcohol consumption or alcohol-containing products and cannot abstain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ivabradine 0-36 hours Cmax, AUC0-tlast and AUC0-infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| Ivabradine 0-36 hours Tmax, t1/2, lamda z, AUC0-tlast/AUC0-infinity | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed