Condition category
Digestive System
Date applied
03/09/2009
Date assigned
03/11/2009
Last edited
03/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr HuiJeong Kim

ORCID ID

Contact details

Abbott Korea Limited
th Floor
Sam Tan Building
947-3 DaeChi-Dong
KangNam-Ku
Seoul
135-735
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KORE-08-02

Study information

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

Acronym

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

Seoul National University College of Medicine/Seoul National University Hospital Institutional Review Board approved on the 25th February 2009

Study design

Randomised open-label three-sequence three-period single centre crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase I

Drug names

Itopride hydrochloride

Primary outcome measures

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 trial start date

10/03/2009

Overall trial end date

10/07/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

24

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

Trial participating centre

Abbott Korea Limited
Seoul
135-735
Korea, South

Sponsor information

Organisation

Abbott Korea Limited (South Korea)

Sponsor details

6th Floor
Sam Tan Building
947-3 DaeChi-Dong
KangNam-Ku
Seoul
135-735
Korea
South

Sponsor type

Industry

Website

http://www.abbott.co.kr

Funders

Funder type

Industry

Funder name

Abbott Korea Limited (South Korea)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes