Thai healthy male and female subjects , Aged 18 to 55 years , BMI were within 18-30 kg/m2 , Good health confirming by physical and clinical. Itopride, Bioequivalence study
Conditions
Interventions
a single oral of generic product, itopride 50 mg film coated tablet, under fasting condition, 26 subjects cross over with arm 2,a single oral of innovator product, itopride 50 mg film coated tablet, u
Experimental Drug,Experimental Drug
generic product of itopride,innovator product of itopride
Sponsors
Macrophar Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Thai male and/or female age between 18-55 years 2. Has body mass index (BMI) between 18.0-30.0 kg/m2 3. Has been determined healthy by physical examination, assessment of medical history, and vital signs (blood pressure (systolic blood pressure not lower than 90 or not over 139 mmHg, diastolic blood pressure not lower than 60 or not over 89 mmHg), body temperature, pulse rate, respiratory rate) or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians 4. Has normal or acceptable results (being assessed as not clinically significant by the principal investigator/clinical investigator) for all screening tests including: Complete Blood Count (CBC) with differential, Fasting Blood Sugar (FBS), Blood Urea Nitrogen (BUN), Creatinine (Cr), Aspartate Aminotransferase (AST or SGOT), Alanine Aminotransferase (ALT or SGPT), Alkaline Phosphatase (ALP), Albumin, Total Bilirubin, 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. 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 at screening and prior to dosing at period 1 and period 2. 8. Female subjects who is childbearing potential or male subjects agree to use effective non-hormonal contraceptive methods (e.g., condom, diaphragm, cervical cap or sexual abstinence) or total abstinence from sexual intercourse from screening visit to the follow-up visit. 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. Non-smokers (never smoked or no smoking within the previous 1 year) 11. Refrain from using herbal medications, cannabis containing products, dietary supplements, vitamins, grapefruit or grapefruit juice, or pomelo within 14 days prior to Day 1. Subjects must agree to refrain from these items until the last collection time-point of period 2. 12. Subjects must have ended the systematic medications at least 30 days prior to Day 1 and agree to continue their 13. Subjects must refrain from drinking caffeine and alcohol for at least 72 hours prior to Day 1 and agree to continue their refraining throughout the last collection time-point of period 2. 14. Has ability and intention to comply with the requirement of study and available for the whole study period. 15. Willing to participate, capable and voluntarily signed the informed consent form prior to participate the study
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Itopride hydrochloride and/or related structure and/or its constituents. 2. Has history or concurrent symptoms of cardiovascular, gastrointestinal, hematological disorders, renal and hepatic impairment and/or any disease that may affect the bioavailability of the drug. 3. Alcohol abuse or excessive use (more than 1 time/week) in the last 12 months 4. Alcohol breath test at screening visit or before admission show alcohol concentration more than 0.000 %BAC. 5. History of drug abuse or urine sample shows a positive test for Morphine (Mor), Tetrahydrocannabinol (THC) and Methamphetamine (Meth) at screening visit or before IP dosing in each period. 6. Following a special diet (e.g., vegetarian) or dieting one month before the study initiation. 7. A pregnant woman (positive pregnancy test at screening or prior to IP dosing in each period) or woman in breast feeding period 8. A woman of childbearing potential and using hormonal contraceptive methods including oral contraceptives, hormone replacement therapy and transdermal contraceptives within 14 days prior to IP 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 IP dosing and during the entire period of the study 9. A participant in any investigation drug study within last 30 days prior to screening (from the last visit that received medication to the screening visit) 10. Has blood donated or loss massive blood within last 3 months prior to Day 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence 12 months 90% confidence interval of Cmax, AUC0-t and AUC0-inf | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters 12 months Cmax, Tmax, AUC, Half-life | — |
Countries
Thailand
Contacts
Public ContactNantaporn Prompila
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed