Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects

A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01332890

Enrollment

Registered

2011-04-11

Start date

2011-04-30

Completion date

2011-08-31

Last updated

2014-07-10

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

Conditions

Healthy

Keywords

Drug interaction, revaprazan, Itopride HCI

Brief summary

To evaluate drug-drug interaction

Detailed description

The main objective is to evaluate the pharmacokinetic profile of the 50mg Revaprazan plus 50mg Itopride compared to 50mg Revaprazan or 50mg Itopride alone in healthy Korean subjects

Interventions

OTHERSequence 1

Period1(A) Period2(B) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)

OTHERSequence 2

Period1(C) Period2(A) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)

OTHERSequence 3

Period1(B) Period2(C) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)

OTHERSequence 4

Period1(C) Period2(B) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)

OTHERSequence 5

Period1(B) Period2(A) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)

OTHERSequence 6

Period1(A) Period2(C) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Males aged 20 to 50 years old, with a body mass index (BMI) between 19 and 27 kg/m2 * Acceptable medical history, physical exam,laboratory tests and EKG, during screening * Eligible for blood sampling during study period * Provision of signed written informed consent

Exclusion criteria

* History of any clinically significant disease * History of drug/chemical/alcohol abuse * Clinically significant illness or within 30days before the first dose * Use of medication known to chronically alter drug absorption or elimination processes within 30days before the first dose of investigational product * Use of prescribed medication during the 14 days before administration of the first dose of investigational product * Use of any non-prescribed medication during the 7 days before administration of the first dose of investigational product - Use of any oriental medication medication during the 30 days before administration of the first dose of investigational product * Participated in a clinical study involving administration of an investigational drug (new chemical entity) or a marketed drug within past 90 days * Consuming more than 21 units of alcohol per week * Smoking more than 20 cigarettes per day or consuming more than 5 cups of caffeinated beverages.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics	Blood sampling will be obtained on day 7 at each period.	Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026