Trials / Completed
CompletedNCT04150172
To Evaluate Pharmacokinetics and Safety of Two Different Formulation of Rebamipide in Healthy Volunteers
A Randomized, Open Label, Multiple Dose, Crossover Study to Compare the Safety and Pharmacokinetics Between "Rebamipide Sustained Release (SR) 150mg" and "Rebamipide Immediate Release (IR) 100mg" in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 19 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, open label, multiple dose, crossover study to compare the safety and Pharmacokinetics (PKs) between two rebamipide formulations after multiple oral doses of "rebamipide SR 150 mg" and "rebamipide IR 100 mg" in healthy adult volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rebamipide SR 150mg | Test drug |
| DRUG | Rebamipide IR 100mg | Reference Drug |
Timeline
- Start date
- 2019-04-22
- Primary completion
- 2019-05-01
- Completion
- 2019-05-10
- First posted
- 2019-11-04
- Last updated
- 2019-11-04
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04150172. Inclusion in this directory is not an endorsement.