Comparison of pharmacokinetics between immediate-release tablets and controlled-release tablets of mosapride citrate

A phase 1, randomized, open-label, single dose, 3-treatment, 3-period Williams-design to assess the pharmacokinetic characteristics and food effect of mosapride citrate controlled-release tablets compared with mosapride citrate immediate-release tablets in healthy male subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0003351

Enrollment

Registered

2018-11-16

Start date

2012-02-06

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : A total of 6 sequences were processed by permutation. Each sequence consists of 3 kinds of treatments (single oral administration of one test product (controlled-release tablets of mosapride ci

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy male adult. 2. Total body weight is at least 55 kg and within 20% of ideal body weight. 3. No morbid conditions or findings under medical examinations. No congenital disorders or chronic diseases. 4. No clinically relevant abnormalities identified by laboratory tests. 5. A personally signed and dated informed consent documents indicating that the subject has been informed of all pertinent aspects of the trial.

Exclusion criteria

Exclusion criteria: 1. Any previous history of intolerance or allergic reaction to mosapride citrate, gastroprokinetcs, or antispasmodics. 2. Blood pressure equal to or more than 145 mmHg systolic or 95 mmHg diastolic. blood pressure equal to or less than 100 mmHg systolic or 50 mmHg diastolic, or pulse rate exceeding 100 bpm. 3. Evidence or history of clinically significant diseases. 4. 12-lead ECG demonstrating atrial ectopy, ventricular ectopy, atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, multifocal ventricular ectopic beats, or QTc > 450 msec. 5. Gastriintestinal disorders affecting the abosorption of investigational drugs. 6. Treatments for peptic ulcer or gastrointestinal tract bleeding, or clinically related histories within 2 months prior to the first dose. 7. Regular alcohol consumption exceeding 21 units/week. Unable to stop drinking or smoking during the study. 8. Treatments with an investigational drug within 3 months prior to the first dose of trial medications. 9. Whole blood donations within 2 months, or apheresis within 1 month prior to the first dose of investigational products. 10. Use of cytochrome P450 inducers or inhinitors within 1 month prior to the first dose of trial medications. 11. Use of prescription or herbal medicines within 2 weeks, or non-prescription drugs within 1 week prior to the first dose of study drugs. 12. Psychiatric illnesses, drug abuse, alcohol abuse. 13. Subjects considered ineligible by investigators. 14. Intake of grapefruit juice or grapefruit-containing products within 1 week prior to the first dose of investigational drugs. 15. History of drug abuse. 16. Galatose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.

Design outcomes

Primary

Measure	Time frame
Area unter time-concentration curve for 24 hours;Peak plasama concentration	—

Secondary

Measure	Time frame
Time to peak plasma concentration;Apparent clearance	—

Countries

Korea, Republic of

Contacts

Public ContactJaeWoo Kim

Chungnam National University Hospital

zeusy@cnuh.co.kr+82-42-280-6941

Outcome results