A Bioequivalence Study of Two Formulations of Atorvastatin Calcium Equivalence to Atorvastatin 40-mg Tablets in Healthy Thai Volunteers under Fasting Conditio
- Conditions
- ipid lowering agentAtorvastatin,Bioequivalence
- Registration Number
- TCTR20190902003
- Lead Sponsor
- ovartis (Thailand) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 48
A subject will be eligible for study participation if he/she meets the following criteria:
1.Male/Female must be 18-55 years of age, body mass index (BMI) = 18.0-25.0 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 clinical investigator
3.Screening electrocardiogram (ECG) without clinically significant abnormalities.
4.Screening visit laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasted 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 clinical investigator.
5.Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of clinical investigator.
6.Must have serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus antibody (anti-HIV) seronegative
7.Female subjects must have serum β-hCG negative.
8.Female subject who is childbearing potential 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 (IUD), 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 I and period II.
11. Non-smokers (never smoked or no smoking within the previous 1 year).
12.Refrain from using herbal medications, dietary supplements (e.g., St. John’s Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of study drug (Day 1). Subjects must refrain from these items until the last collection time-point of period II.
13.Subjects must have ended any medications at least 30 days prior to Study Day 1 and agree to continue their refraining throughout the follow up period.
14.Subjects must refrain from drinking caffeine and alcohol for at least 72 hours prior to study day 1 and agree to continue their refraining throughout the last collection time-point of period II.
15.Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
A subject will not be eligible for study participation if he/she meets the following criteria:
1.Known hypersensitivity to atorvastatin and its components.
2.Known of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
3.Past medical history of renal and hepatic insufficiency
4.Subject has a history of any illness that, in the opinion of the investigator, 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.Have history of drug abuse (in the opinion of the investigator, 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)), cannabiniods (tetrahydrocannabinol (THC)), methamphetamine (Meth), cocaine (Coc) and methylenedioxy-methamphetamine (MDMA) at screening visit or before dose administration at each period
6.Alcohol abuse or excessive use (in the opinion of the investigator, 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 high-fat and high-calorie meals
10.Difficulties swallowing whole tablets
11.Donation or loss of whole blood:
a.≥ 50 mL and ≤ 499 mL within 30 days prior to dosing
b.≥ 500 mL within 56 days prior to dosing.
12.Participation in any investigation drug study within 1 month from screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Atorvastatin level in plasma 23 Time points in 48 hours after dosing Pharmacokinetic parameters: UC0-t, AUC0-∞, Cmax, tmax, t1/2λz and λz of Atorvastatin
- Secondary Outcome Measures
Name Time Method /A N/A N/A