A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Rosuvastatin 20 mg Film-coated Tablet and Reference Product (CRESTOR 20 mg) in Healthy Thai Volunteers under Fasting Conditions
- Conditions
- Bioequivalence Study,Healthy,Thai,VolunteersRosuvastatin,
- Registration Number
- TCTR20191126002
- 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
- 36
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 Non-smoker and/or non-consumer of nicotine containing products.
Non-smoker means any subject who has never smoked or stopped for at least 90 days whereas non-consumer of nicotine containing products means any subject who stopped nicotine containing product consumption for at least 90 days.
4 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.
5 Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
à¸à¸²à¸ªà¸²à¸ªà¸¡à¸±à¸„รเพศหà¸à¸´à¸‡à¹„ม่มีà¸à¸²à¸£à¸•à¸±à¹‰à¸‡à¸„รรภ์ (ผลà¸à¸²à¸£à¸•à¸£à¸§à¸ˆà¸à¸²à¸£à¸•à¸±à¹‰à¸‡à¸„รรภ์ให้ผลลบ) à¹à¸¥à¸°à¹„ม่à¸à¸¢à¸¹à¹ˆà¹ƒà¸™à¸ าวะให้นม
บุตร
6 For female subjects, one of the following must apply:
Females of childbearing potential will have to take appropriate measures to
prevent pregnancy during the study, such as total abstinence or the use of highly
effective contraceptive regimens. Highly effective methods of birth control are
defined as those, alone or in combination that result in a low failure rate (i.e. less
than 1% per year). Below is a list of acceptable contraceptive regimens throughout
the study until duration equal to 1 washout period post last dose:
ï€ combined (estrogen and progesterone containing) hormonal contraceptives
associated with inhibition of ovulation (oral, intravaginal or transdermal) used
for at least 3 consecutive months prior to Period 1 dosing
ï€ progestogen-only hormonal contraceptives associated with inhibition of
ovulation (oral, injectable or implantable) used for at least 3 consecutive months
prior to Period 1 dosing
ï€ intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) used
for at least 3 consecutive months prior to Period 1 dosing
ï€ bilateral tubal occlusion
ï€ condom with intravaginally applied spermicides used for at least 14 days prior to
Period 1 dosing
Females who do not use an acceptable contraceptive regimen or confirm total
abstinence will be allowed to participate in this study only if they are not considered
to be of childbearing potential: females
ï‚· who have had a documented hysterectomy, bilateral oophorectomy, bilateral
salpingectomy or tubal ligation,
ï‚· or who are clinically diagnosed infertile,
ï‚· or who are in a menopausal state (minimum of a year without menses (FSH
level >35 IU/mL + no menses since at least 1 year; subjects statement is
sufficient).
Note: Variations in the FSH levels will be acceptable at the medical discretion of the
Principal Investigator or delegated Clinical Investigator after clinical corelation.
7 For male subjects, one of the following must apply in order to avoid impregnating a
female partner, from the first study dose until duration equal to 1 washout period
post last dose:
ï‚· Abstinence
ï‚· Use of barrier method with spermicide
8 Subjects have understood and voluntarily given written informed consents (signed
and dated) by the subject prior to
1 History of allergic reaction or hypersensitivity to rosuvastatin or to any of the excipients of the product
2 History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo/hyperthyroidism), pulmonary or
respiratory (e.g. allergic rhinitis, asthma), cardiovascular, 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 History of muscular diseases i.e. myopathy, myalgia, rhabdomyolysis, muscle
tenderness or weakness or personal or family hereditary muscular disorders or
history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
4 History or evidence of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption
5 History of problems with swallowing tablet or capsule
6 History of sensitivity to heparin or heparin-induced thrombocytopenia
7 Reports difficulty fasting or consuming standardized meals
8 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy,
gastritis or duodenal or gastric ulceration other than appendectomy
9 History of preceding diarrhea within 24 hours prior to check-in in each period
10 Presence of significant infection within 1 week prior to screening or check-in
11 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana, methamphetamine,
benzodiazepine or cocaine)
12 Have had a tattoo or body piercing within 90 days prior to check-in in Period 1 or during enrollment
13 Reports a clinically significant illness during the 30 days prior to check-in in Period 1 or during enrollment{as determined by the investigator(s)}
14 Pulse rate below 60 beats/minute or above 100 beats/minute
15 Systolic blood pressure less than 90 mmHg or more than 139 mmHg. Diastolic blood pressure less than 60 mmHg or more than 89 mmHg. Minor deviations (2-4 mmHg) at check-in may be acceptable at the discretion of the physician/
investigator.
16 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’s
eligibility.
17 Investigation with blood sample shows positive test for HBsAg, Anti-HCV or AntiHIV
18 Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for
ALT, AST or bilirubin levels at screening laboratory test
19 Creatine kinase levels ≥ 1.5 times of upper normal limit of reference range (unless
explained by exercise) at screening laboratory test
20 Have renal creatinine clearance (Clcr) <30 mL/min based on serum creatinine
results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the
screening laboratory test
21 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rosuvastatin plasma concentrations 0-96 hr. Cmax, AUC0-tlast and AUC0-∞
- Secondary Outcome Measures
Name Time Method Rosuvastatin plasma concentrations 0-96 hrs. Tmax, t1/2, AUC0-tlast/AUC0-∞, AUC%extrapolate, λz and MRT