NCT01332890

Brief Summary

To evaluate drug-drug interaction

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

April 7, 2011

Last Update Submit

July 8, 2014

Conditions

Healthy

Keywords

Drug interactionrevaprazanItopride HCI

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis.

    Blood sampling will be obtained on day 7 at each period.

Study Arms (6)

Sequence 1

EXPERIMENTAL
Other: Sequence 1

Sequence 2

EXPERIMENTAL
Other: Sequence 2

Sequence 3

EXPERIMENTAL
Other: Sequence 3

Sequence 4

EXPERIMENTAL
Other: Sequence 4

Sequence 5

EXPERIMENTAL
Other: Sequence 5

Sequence 6

EXPERIMENTAL
Other: Sequence 6

Interventions

Sequence 1OTHER

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)

Sequence 1
Sequence 2OTHER

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)

Sequence 2
Sequence 3OTHER

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)

Sequence 3
Sequence 4OTHER

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)

Sequence 4
Sequence 5OTHER

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)

Sequence 5
Sequence 6OTHER

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)

Sequence 6

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASAN Medical Center, University of Ulsan

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 11, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

KR(1)