ISRCTN36928353CompletedNot Applicable
A comparison of bioavailability of itopride hydrochloride extended release (once daily) with that of itopride hydrochloride immediate release (three times daily): a randomised, open-label, three treatment, three sequence crossover study
Abbott Korea Limited (South Korea)0 sites24 target enrollmentStarted: November 3, 2009Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Male
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
- •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
Investigators
Similar Trials
Completed
Phase 1
Bioequivalence Study of 50 mg Itopride HCL film-coated Tablets in Healthy Thai VolunteersBioequivalence Study of 50 mg Itopride HCL film-coated Tablets in Healthy Thai VolunteersTCTR20211103001nison Laboratories Co., Ltd.28
Completed
Phase 2
Efficacy and Safety Study of the Ivabradine Hydrochloride Tablets versus Atenolol Tablets in Patients With Chronic Stable Angina Pectoris.Coronary heart diseaseCardiovascular - Coronary heart diseaseACTRN12613000354785Fu Wai Hospital336
Not yet recruiting
Unknown
A pilot study to check the efficacy of Itopride Hydrochloride prolonged release capsule (Ganaton OD; 150 mg) in diabetic gastroparesis patients with dyspepsiaCTRI/2023/09/057158Abbott India Ltd.
Completed
Not Applicable
A study to compare Bioavailability of Hydrocortisone 25 mg and 45 mg Suppository with Hydrocortisone foam and tablet in Healthy Adult VolunteersCTRI/2019/02/017469Genus Lifesciences Inc20
Completed
Phase 1
A study of a new primaquine 5 mg formulation in healthy volunteersRBR-105nyj86Fundação Oswaldo Cruz