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
Overview
- Phase
- Phase 1
- Intervention
- Rebamipide
- Conditions
- Healthy
- Sponsor
- IlDong Pharmaceutical Co Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- AUCτ,ss of Mosapirde citrate 5mg
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
R - R+M
R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.
Intervention: Rebamipide
R - R+M
R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.
Intervention: Mosapride citrate
R+M - R
R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.
Intervention: Rebamipide
R+M - R
R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.
Intervention: Mosapride citrate
M - R+M
R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.
Intervention: Rebamipide
M - R+M
R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.
Intervention: Mosapride citrate
R+M - M
R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.
Intervention: Rebamipide
R+M - M
R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.
Intervention: Mosapride citrate
Outcomes
Primary Outcomes
AUCτ,ss of Mosapirde citrate 5mg
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
- 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)
- t1/2 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)
- Cmin,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)
- AUClast,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)
- AUCinf,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)
- Tmax,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)