Clinical trial NCT02106130: A Drug Interaction Study of Mosapride and Rebamipide
Official title: A Randomized, Open-label, Multiple Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Mosapride Citrate and Rebamipide After Oral Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Mosapride citrate
Rebamipide
pharmacokinetic drug drug interaction
oral administration
healthy male subjects
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: To evaluate the safety, drug-tolerance, pharmacokinetics of Mosapride citrate 5 mg or Rebamipide 100 mg monotherapy or Mosapride citrate 5 mg and Rebamipide 100 mg combination in healthy male subjects.

Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers, age 20 to 45 years
2. Body weight ≥ 55kg (male), ≥ 50kg (female)
3. Body weight index (BMI) 18.5 \~ 25
4. Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
5. 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.

Exclusion Criteria:

1. 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).
2. 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.
3. Subject has hypersensitivity reaction to drug (aspirin, antibiotics, including study durgs, etc.) or history of clinically significant hypersensitivity reaction.
4. Systolic blood pressure \> 150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg or \<50mmHg(Sitting blood pressure) during the screening procedure
5. Subject has history of drug abuse or tested positive to abused drug in the urine drug screening test.
6. For women, pregnant or breastfeeding woman or woman who was confirmed to be pregnant in the pregnancy test
7. Subject takes caffeine-containing food 5 cups per day
8. Subject continually drinks (in excess of 210g/week)
9. Subject smokes 10 cigarettes or more in one day
10. 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).
11. A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 30 days prior to the first dosing
12. Subject participated in another study and received medication within 2 months prior to the first medication day.
13. 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.
14. Subject was judged not to be eligible according to the discretion of the investigator for other reasons.

Primary outcomes:
measure: AUCτ,ss of Mosapirde citrate 5mg
timeFrame: 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
measure: Cmax,ss of Mosapirde citrate 5mg
timeFrame: 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
measure: AUCτ,ss of Rebamipide 100mg
timeFrame: 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
measure: Cmax,ss of Rebamipide 100mg
timeFrame: 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:
measure: AUClast,ss of Mosapride citrate 5mg
timeFrame: 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
measure: AUCinf,ss of Mosapride citrate 5mg
timeFrame: 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
measure: Tmax,ss of Mosapride citrate 5mg
timeFrame: 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
measure: t1/2 of Mosapride citrate 5mg
timeFrame: 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
measure: Cmin,ss of Mosapride citrate 5mg
timeFrame: 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
measure: AUClast,ss of Rebamipide 100mg
timeFrame: 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
measure: AUCinf,ss of Rebamipide 100mg
timeFrame: 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
measure: Tmax,ss of Rebamipide 100mg
timeFrame: 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
measure: t1/2 of Rebamipide 100mg
timeFrame: 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
measure: Cmin,ss of Rebamipide 100mg
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Yonsei University Health System, Severance Hospital
name: Chun-ok Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: