CompletedNCT01332890Updated Jul 10, 2014

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

A Phase 1 interventional study of Sequence 1 and Sequence 2 in Healthy, sponsored by Yuhan Corporation. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-10.

Sponsored by Yuhan Corporation · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 20 Years to 50 Years
Sex: Male

Study summary

To evaluate drug-drug interaction

Read the 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

Conditions studied

Healthy

Keywords

Drug interaction
revaprazan
Itopride HCI

In context

Lead sponsor

Yuhan Corporation is the lead sponsor of 107 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 50 Years
Sexes eligible: Male
Accepts 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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
Sequence 1
Other: Sequence 1
Experimental
Sequence 2
Other: Sequence 2
Experimental
Sequence 3
Other: Sequence 3
Experimental
Sequence 4
Other: Sequence 4
Experimental
Sequence 5
Other: Sequence 5
Experimental
Sequence 6
Other: Sequence 6

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)

What researchers measure

Primary outcomes

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

Study locations

1 site

ASAN Medical Center, University of Ulsan
Seoul, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01332890
Lead sponsor: Yuhan Corporation
Responsible party: Sponsor
First posted: Apr 11, 2011
Start date: Apr 2011
Primary completion: Aug 2011
Completion: Aug 2011
Last update: Jul 10, 2014

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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