Gastrointestinal motility Digestive System Other diseases of digestive system
Conditions
Interventions
1. Study drug: itopride HCl, 150 mg, 3 times a day for 6 days, per oral
2. Comparator: itopride HCl, 50 mg, 3 times a day for 6 days, per oral
Total duration of treatment: 21 days (7 days per each r
Sponsors
Abbott Korea Limited (South Korea)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Korean males aged between 22 and 55 years, inclusive (at time of informed consent) 2. Body mass index (BMI) 18 to 27 kg/m^2, inclusive. BMI is calculated as weight (kg) divided by the square of height (m). 3. A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) 4. Subjects who have given their written informed consent prior to participation in the study 5. Availability of subject for the entire study period, ability to understand and communicate with the investigators and staff, and willingness to adhere to protocol requirements including all the restrictions
Exclusion criteria
Exclusion criteria: 1. History or clinical evidence of significant respiratory, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatological, musculoskeletal, neurological or psychiatric disease 2. Alcohol dependence, alcohol abuse or drug abuse within the past one year 3. Moderate to heavy smoking (greater than 10 cigarettes/day) 4. Body weight is less than 50 kg 5. Subject who had clinically significant illness within 4 weeks before the start of the study 6. Present or previous significant drug allergy to any prescription or over-the-counter medication 7. Subjects who test positive in serological tests and drug tests (serological tests for hepatitis B surface [HBs] antigen, hepatitis C virus [HCV] antibody, and human immunodeficiency virus [HIV] antibody, and screening for drug abuse) 8. Any history of hypersensitivity to itopride and contraindications like gastrointestinal haemorrhage, mechanical obstruction or perforation 9. Subjects with active or a history of peptic ulceration 10. Subjects with any other clinical condition, which might affect the absorption, distribution, biotransformation or excretion of the study drug 11. Subject who has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood (or had bled more than 400 ml) in the preceding 12 weeks period of the study 12. Any prescription drug, over-the-counter medication, or herbal medications within 14 days prior to scheduled study drug administration 13. Consumption of alcohol within the 1-day period prior to study drug administration 14. Subjects who show the following vital signs results 14.1. Systolic blood pressure less than or equal to 90 mmHg or greater than or equal to 150 mmHg 14.2. Diastolic blood pressure less than or equal to 60 mmHg or greater than or equal to 100 mmHg 15. Subjects who have pulse rate below 50/minute or above 100/minute 16. Previous enrolment in this study 17. Otherwise judged by the investigator to be inappropriate for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the rate and extent of absorption of itopride from itopride ER tablets under fasting and fed conditions compared to that of itopride IR tablets based on pharmacokinetic parameters. Timepoint: study day 4 of each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Observe the safety of the formulations based on clinical and laboratory examinations during the study. Timepoint: at screening day, day -1 of study period 2, day 5 of study period 3. | — |
Countries
Korea, South
Outcome results
None listed