Bioequivalence Study of Amlodipine Besylate and Valsartan 10/160 mg Film-coated Tablets in Healthy Thai Volunteers
- Conditions
- Healthy volunteerAmlodipine Besylate and Valsartan, Bioequivalence Study, Healthy Thai Volunteer
- Registration Number
- TCTR20230922002
- Lead Sponsor
- International Bio Service Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 78
1. Healthy Thai male or female subjects between the ages of 18 to 55 years., 2. Body mass index between 18.5 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 14 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 14 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
1. History of hypersensitivity to amlodipine, valsartan or to any of the excipients., 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), 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 about administration of COVID-19 vaccine within 30 days prior to check-in in each Period., 5. History or evidence of severe hypotension, 6. History or evidence of severe hepatic impairment, biliary cirrhosis or cholestasis, 7. History or evidence of shock (including cardiogenic shock), 8. History or evidence of myocardial infarction, heart failure, aortic and mitral valve stenosis or obstructive hypertrophic cardiomyopathy, 9. History or evidence of renal artery stenosis, 10. History or evidence of peripheral edema, 11. History or evidence of volume depletion, 12. Investigation with blood sample shows level of potassium less than 3.5 or more than 5.0 mmol/L at screening laboratory test.,13. Have glomerular filtration rate (GFR; Cockcroft-Gault formula) < 60 mL/min/1.73 m2 based on serum creatinine results, using, at the screening laboratory test, 14. History of sensitivity to heparin or heparin-induced thrombocytopenia15. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy, 16. History of diarrhea or vomiting within 24 hours prior to check-in in each period, 17. History of problems with swallowing tablet or capsule, 18. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine), 19. 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 subjects eligibility., 20. 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 subjects eligibility., 21. Investigation with blood sample shows positive test for HBsAg., 22. Abnormal liver function, >=1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test, 23. 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, 24. 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 m
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma amlodipine and valsartan concentrations 0.00-72.00 hours post-dose Cmax and Truncated AUC0-72 for amlodipine, and Cmax, AUC0-tlast and AUC0-inf for valsartan
- Secondary Outcome Measures
Name Time Method Plasma amlodipine and valsartan concentrations 0.00-72.00 hours post-dose Tmax, t1/2 and Kel for amlodipine, and Tmax, t1/2, AUC0-tlast/AUC0-inf, AUC%extrapolate, Kel and MRT for valsartan