The bioavailability of itopride hydrochloride extended release versus itopride hydrochloride immediate release
| ISRCTN | ISRCTN36928353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36928353 |
| Secondary identifying numbers | KORE-08-02 |
- Submission date
- 03/09/2009
- Registration date
- 03/11/2009
- Last edited
- 03/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr HuiJeong Kim
Scientific
Scientific
Abbott Korea Limited
th Floor, Sam Tan Building
947-3 DaeChi-Dong
KangNam-Ku
Seoul
135-735
Korea, South
Study information
| Study design | Randomised open-label three-sequence three-period single centre crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study hypothesis | The objective of this study is to assess the bioavailability of a test formulation of itopride hydrochloride 150 mg extended release (ER) tablets (once daily for 4 days) given under fasting and fed conditions relative to itopride hydrochloride 50 mg immediate release (IR) tablets given three times daily for 4 days, in healthy human adult male subjects. |
| Ethics approval(s) | Seoul National University College of Medicine/Seoul National University Hospital Institutional Review Board approved on the 25th February 2009 |
| Condition | Gastrointestinal motility |
| Intervention | 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 regimen) Regimen A: Administration of itopride HCl 150 mg ER tablet every 24 hours under fasting conditions for 4 days (test) Regimen B: Administration of itopride HCl 150 mg ER tablet every 24 hours under fed condition for 4 days (test) Regimen C: Administration of itopride HCl 50 mg IR tablet administration for 4 days, 30 minutes before meals (reference). Meals will be provided at approximately 9am, 2pm and 7pm. Total duration of follow-up: 30 days (window period: +6 days) Contact Details of Principal Investigator: Prof In-Jin Jang Department of Pharmacology and Clinical Pharmacology Seoul National University College of Medicine 101 Daehangno Jongno-gu Seoul 110-744 South Korea |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Itopride hydrochloride |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 10/03/2009 |
| Overall study end date | 10/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Male |
| Target number of participants | 24 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 10/03/2009 |
| Recruitment end date | 10/07/2009 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Abbott Korea Limited
Seoul
135-735
Korea, South
135-735
Korea, South
Sponsor information
Abbott Korea Limited (South Korea)
Industry
Industry
6th Floor, Sam Tan Building
947-3 DaeChi-Dong
KangNam-Ku
Seoul
135-735
Korea, South
| Website | http://www.abbott.co.kr |
|---|---|
"ROR" |
https://ror.org/053evkn98 |
Funders
Funder type
Industry
Abbott Korea Limited (South Korea)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
