NCT02106130

Brief Summary

The investigators investigate the potential pharmacokinetic drug-drug interaction between Mosapride citrate 5 mg and Rebamipide 100 mg in healthy male volunteers who receive Mosapride citrate 5 mg, Rebamipide 100 mg, and both together in a 2 period repeatedly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
Last Updated

April 8, 2014

Status Verified

March 1, 2014

Enrollment Period

1 month

First QC Date

March 12, 2014

Last Update Submit

April 3, 2014

Conditions

Healthy

Keywords

Mosapride citrateRebamipidepharmacokinetic drug drug interactionoral administrationhealthy male subjects

Outcome Measures

Primary Outcomes (4)

  • AUCτ,ss of Mosapirde citrate 5mg

    D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose

  • Cmax,ss of Mosapirde citrate 5mg

    D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose

  • AUCτ,ss of Rebamipide 100mg

    D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose

  • Cmax,ss of Rebamipide 100mg

    D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose

Secondary Outcomes (10)

  • AUClast,ss of Mosapride citrate 5mg

    D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose

  • AUCinf,ss of Mosapride citrate 5mg

    D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose

  • Tmax,ss of Mosapride citrate 5mg

    D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose

  • t1/2 of Mosapride citrate 5mg

    D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose

  • Cmin,ss of Mosapride citrate 5mg

    D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose

  • +5 more secondary outcomes

Study Arms (4)

R - R+M

EXPERIMENTAL

R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.

Drug: RebamipideDrug: Mosapride citrate

R+M - R

EXPERIMENTAL

R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.

Drug: RebamipideDrug: Mosapride citrate

M - R+M

EXPERIMENTAL

R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.

Drug: RebamipideDrug: Mosapride citrate

R+M - M

EXPERIMENTAL

R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.

Drug: RebamipideDrug: Mosapride citrate

Interventions

RebamipideDRUG

oral administration, 3 times/day

Also known as: Mucosta® Tab.
M - R+MR - R+MR+M - MR+M - R
Mosapride citrateDRUG

oral administration, 3 times/day

Also known as: Gasmotin® tab.
M - R+MR - R+MR+M - MR+M - R

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers, age 20 to 45 years
  • Body weight ≥ 55kg (male), ≥ 50kg (female)
  • Body weight index (BMI) 18.5 \~ 25
  • Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
  • Subject decided to participate voluntarily and gave written Informed consent to comply with the instructions after listening to and fully understanding the detailed explanation about this trial.

You may not qualify if:

  • Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic·oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).
  • Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.
  • Subject has hypersensitivity reaction to drug (aspirin, antibiotics, including study durgs, etc.) or history of clinically significant hypersensitivity reaction.
  • Systolic blood pressure \> 150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg or \<50mmHg(Sitting blood pressure) during the screening procedure
  • Subject has history of drug abuse or tested positive to abused drug in the urine drug screening test.
  • For women, pregnant or breastfeeding woman or woman who was confirmed to be pregnant in the pregnancy test
  • Subject takes caffeine-containing food 5 cups per day
  • Subject continually drinks (in excess of 210g/week)
  • Subject smokes 10 cigarettes or more in one day
  • Subject took any prescribed drug or oriental medicine within 2 weeks prior to the first medication or any over-the-counter (OTC) drug within 1 week prior to the first medication (however, the subject can be included if other criteria are met according to the discretion of the investigator).
  • A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 30 days prior to the first dosing
  • Subject participated in another study and received medication within 2 months prior to the first medication day.
  • Subject received whole blood transfusion (500 mL) within 2 months prior to the first medication or blood transfusion within 1 month prior to the first medication.
  • Subject was judged not to be eligible according to the discretion of the investigator for other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

rebamipidemosapride

Study Officials

  • Chun-ok Kim, MD

    Yonsei University Health System, Severance Hospital

    PRINCIPAL INVESTIGATOR

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

March 12, 2014

First Posted

April 8, 2014

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

April 8, 2014

Record last verified: 2014-03

Locations

KR(1)