A Single dose, randomized, open-label, two-way crossover bioequivalence study of generic Rosuvastatin 20 mg film-coated tablets and reference product in healthy Thai Volunteers under fasting conditions

Phase 1

• Conditions: Bioequivalence of generic rosuvastatin

• Registration Number: TCTR20170614004
• Lead Sponsor: GETZ PHARMA INTERNATIONAL FZ LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-14
• Study Completion: 2017-10-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.Healthy Thai male/female subjects between the ages of 18 to 55 years
2.Body mass index between 18.0-25.0 kg/m2
3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests
4.Non-pregnant woman (negative pregnancy test) and not currently breast feeding
5.Female subjects abstain from either hormonal method of contraception or hormone replacement therapy for at least 28 days prior to admission in period 1
6.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study
7.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study

Exclusion Criteria

1.History of allergic reaction or hypersensitivity to rosuvasatin or related structure or any of the component of the formulation
2.History or evidence of clinically significant renal, heptatic, gastrointestinal hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric disorder, neurologic or allergic disease or any significant ongoing chronic medical illness
3. History of muscular disease or 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 glucose-galactose malabsorption
5.History of problems with swallowing tablet
6.History of sensitivity to heparin or heparin-induced thrombocytopenia
7.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
8.History of preceding diarrhea within 24 hrs prior to admission in each period
9.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse
10.12-lead ECG demonstrating QTc>450 msec, a QRS interval > 120 msec or with an abnormality considered clinically significant at screenign
11.Investigation with blood sample shows positive test for HBsAg.
12.Abnormal liver function, >=1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
13.Creatine kinase levels >=1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test
14.Renal creatinine clearance (CLcr) <30 mL/min based on serum creatinince results at the screening laboratory test
15.History or evidence of habitual use of tobacco or nicotine containing products
16.History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products
17.History evidence of habitual consume of tea, coffee, xanthine or caffeine containing products
18.Consumption of grapefruit juice/orange/pomegranate/ its supplement/containing products
19.Use of prescription or nonprescription drugs (e.g. paracetamol, erythromycin, ketoconazole, etc.), herbal medications or supplements, vitamins, mineral or dietary supplements within 14 days prior to admission in Period 1 or during enrollment
20. Participated in other clinical trial within 90 days or ongoing long-term clinical trial prior to admission in Period 1 (except for the subjects who dropped out/withdrawn from the previous study prior to Period 1 dosing) or during enrollment
21.Blood donation or blood loss> 1 unit (1 unit=350-450 mL of blood) within 90 days prior to admission in Period 1 or during enrollment
22. Subjects with poor venous access or intolerant to venepuncture
23. Unwilling or unable to comply with scheduled visits, treatment plan and other study procedures until end of study
24.Inability to communicate wel that may impair the ability to provide written informed consent or cooperate with clinical team
25.Subject who are employees of International Bio Service Co. Ltd., Getz Pharma International FZ LLC, Getz Pharma (PVT.) Ltd. or LF Asia (Thailand) Limited
remark: Criteria for habitual use or regular beverage or regular smoke consumption will be followed SOPs of CRD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC0-t,AUC0-inf, Cmax 0,0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Drug concentration in plasma,AUC0-t/AUC0-inf,Tmax, t1/2, AUC%extrapolate, MRT, 0,0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Drug concentration in plasma

Secondary Outcome Measures

Name	Time	Method
Adverse event : Symptoms assessment 0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Asking the question 'How do you feel?', Vital signs, Physical examination,Adverse event : Nephrotoxicity 0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Collection of urine specimens ,Adverse event : Cardiotoxicity 0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Electrocardiogram (ECG)