An Open Label, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Oral Dose, Crossover BE Study of Rozacor (20 mg) of The Government Pharmaceutical Organization, Thailand with CRESTOR of IPR Pharmaceuticals Inc., Puerto Rico, in Healthy Human Subjects under Fasting Conditions
- Conditions
- Healthy male and female subjectsBioequivalence fed conditions
- Registration Number
- TCTR20210521001
- Lead Sponsor
- The Government Pharmaceutical Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 50
a) Be healthy male and female subjects between 18-55 years of age (both inclusive).
b) Have a Body Mass Index (BMI) between 18.0-30.0 (both inclusive), calculated as weight in kg/height in m2.
c) Have no evidence of underlying disease or clinically significant abnormal finding during screening, medical history examination, physical examination.
d) Have no abnormal finding during laboratory examination such as complete blood count, hematocrit, hemoglobin, fasting blood sugar, blood urea nitrogen (BUN), serum creatinine, creatine phosphokinase (CPK), creatinine clearance (CrCl), alkaline phosphatase, ALT, AST, total bilirubin, total protein, albumin, HBsAg, Anti-HCV, Anti-HIV, urine analysis, chest X-ray and 12-Lead ECG recording or judged by physician as clinically insignificant or acceptable.
e) Able to understand and comply with the study procedures, in the opinion of the Principal Investigator.
f) Able to give voluntary written inform consent for participation in the trial.
g) In case of female subjects:
- Females of child-bearing potential agree to use an acceptable method of birth control for entire duration of the study as judge by the investigator(s):
i. Non hormonal intrauterine device in place of at least 3 months prior to the start of the study and remaining in place during the study period, or
ii. Barrier methods containing or used in conjunction with a spermicidal agent, such as condoms, foams, jellies, diaphragm, etc., or
iii. Surgery sterilization or
iv. Practicing sexual abstinence throughout the course of the study
OR
- Females were not considered of childbearing potential if one of the following was reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and absence of bleeding for at least 3 month.
AND
- Females demonstrate a negative pregnancy test performed at screening.
- Females without currently breast-feeding.
a) Any history of hypersensitivity to rosuvastatin or any of its excipients.
b) Any history or presence of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
c) A recent history or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
d) Clinically significant illness within 4 weeks before the start of the study.
e) Any history of bronchospasm, asthma, rash, pruritus, urticaria, and angioedema or other allergic type reactions after taking any medication.
f) A positive hepatitis screen including HBsAg and/or anti-HCV.
g) A positive test result for anti-HIV.
h) Has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood (1 unit or 350 mL) in the preceding 90 days prior to the start of the study.
i) History of difficulty with donating blood or difficulty in accessibility of veins.
j) A recent history of 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), or consumption of alcohol or alcoholic product within 48 hours prior to dosing, or testing positive in pre-study breath test for alcohol consumption.
k) Consumption of grapefruit, pomelo, orange, or any products containing these fruits within 48 hours prior to dosing.
l) Consumption of xanthine containing products (i.e. tea, coffee, chocolates or cola drinks) more than 3 cups/day or consuming these products within 24 hours prior to dosing.
m) Heavy smoking (more than 10 cigarettes/day)
n) Moderate smoking (less than 10 cigarettes/day) and consumption of tobacco containing products, which cannot stop smoking or consuming 24 hours prior to dosing and for entire duration of the study.
o) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
p) Consumption of any medication (including over-the-counter products, herbal remedies), or vitamins, or dietary supplements at any time within 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator.
q) Any food allergy, intolerance, restriction or special diet that, in the opinion of Principal Investigator, could contraindicate the volunteer participation in the study.
r) Difficulty in swallowing solids dosage forms like tablets or capsules.
s) Intolerance to venipuncture
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90 % CI pharmacokinetic parameters derived from drug plasma 27 blood sampilng time points (pre-dose (0.000) and 0.333, 0.667, 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.333, 3.667, 4, 4.333, 4.667, 5, 5.5, 6, 7, 8, 10, 12, 16, 24, 36, 48 and 72hrs post-dose. bioanalysis and pharmacokinetic data analysis
- Secondary Outcome Measures
Name Time Method Adverse event/severe adverse event Vital signs will be measured (Pre-dose on day1, 2, 4, 8, 12, 24, 36, 48 and 72 hrs postdose physical and biochemical examination