An Open-label, Single-dose, Two-treatment, Two-period, Two-sequence, Randomized, Crossover Bioequivalence Study of 50 mg Cilostazol Tablets between Test and Reference Product (Pletaal® 50) in Healthy Thai Volunteers under Fasting Conditio
- Conditions
- healthy volunteer
- Registration Number
- TCTR20171128001
- Lead Sponsor
- Siriraj Clinical Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 32
1.Thai male and/or female age between 18-55 years
2.Has body mass index (BMI) between 18.0-25.0 kg/m2
3.Has been determined healthy by physical examination, assessment of drug abuse, medical history, and vital signs
4.Has normal or acceptable results (being assessed as not clinically significant by the clinical investigator) for all screening tests including: complete blood count (CBC), fasting blood sugar (FBS), aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT), alkaline phosphatase (ALP), total bilirubin, blood urea nitrogen (BUN), serum creatinine (Cr), and urinalysis
5.Has negative result for hepatitis B viral profile (HBsAg)
6.Has normal or acceptable report (being assessed as not clinically significant by the clinical investigator) for EKG
7.A woman of childbearing potential and using effective non-hormonal contraceptive methods (e.g., condom, diaphragm, cervical cap or sexual abstinence) for at least 14 days prior to dosing, during the entire period of the study and continue until 7 days after the last sample is collected in period 2
8.A man using effective contraceptive after dosing and continue until 7 days after the last sample is collected in period 2
9.Has ability and intention to comply with the requirement of study and available for the whole study period
10.Willing to participate and voluntarily signed the informed consent form prior to participate the study
1.History of allergic reaction to cilostazol and/or related structure and/or its constituents.
2.Has history or concurrent symptoms of allergy, cardiovascular, liver, kidney, gastrointestinal, hematological disorders and/or any disease that may affect the bioavailability of the drug.
3.Regularly alcohol consumption (more than 1 time/week) and cannot abstain for at least 3 days prior to dosing.
4.Alcohol breath test before admission show alcohol concentration more than 0 mg%.
5.A smoker (smoking within 30 days before screening)
6.History of drug abuse or urine sample shows a positive test for Methamphetamine, Morphine, Tetrahydrocannabinol, Cocaine or Methylenedioxy-methamphetamine.
7.Use of any drugs (except paracetamol) especially which can affect cytochrome P450 enzymes (enzyme inducers e.g., phenobarbital, phenytoin, rifampicin and/or enzyme inhibitors e.g., cimetidine, ketoconazole, erythromycin) within 14 days prior to dosing and willing to taking them throughout participation period
8.Use of paracetamol within 3 days prior to dosing and until after the last sample is collected in each period (Paracetamol taken during this prohibition period can be approved under the consideration of principal investigator or clinical investigator)
9.Use of food supplements, vitamins, minerals and/or herbal remedies within 14 days before dosing and willing to taking them throughout participation period
10.Has drink containing xanthine derivatives or xanthine-related compounds (e.g. coffee, tea, colas, chocolate, caffeine-containing sodas and decaffeinated products) within 3 days prior to dosing and until after the last sample is collected in each period.
11.Has drink or food containing grapefruit and/or orange and/or pomegranate compound within 3 days prior to dosing and until after the last sample is collected in each period.
12.Following a special diet (e.g., vegetarian) or dieting one month before the study initiation.
13.A pregnant woman (positive pregnancy test at screening and/or prior to dosing in each period) and/or woman in breast feeding period
14.A woman of childbearing potential and using hormonal contraceptive methods including oral contraceptives, hormone replacement therapy and transdermal contraceptives within 14 days prior to dosing and during the entire period of the study and/or using injected, intrauterine and implanted hormonal methods of contraception within 3 months prior to dosing and during the entire period of the study
15.A participant in other clinical studies within last 30 days prior to the first dosing
16.Has blood donated and/or blood loss more than 350 mL within last 90 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bioequivalence 6 month 90% geometric confidence interval of Cmax, AUC0-t and AUC0-ing=f
- Secondary Outcome Measures
Name Time Method PK parameter 6 month Cmax and Tmax are taken directly from the individual concentration VS time data