Trials / Completed
CompletedNCT02686294
Repeated Dosing Clinical Trial of HL151
Repeated Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Hanlim Pharm. Co., Ltd. · Industry
- Sex
- Male
- Age
- 19 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple oral administration of TALION tab., a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HL151 | Test drug : HL151. 1T, once a day oral administration, for 4 days |
| DRUG | TALION tab. | Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days |
Timeline
- Start date
- 2016-02-16
- Primary completion
- 2016-03-15
- Completion
- 2016-03-15
- First posted
- 2016-02-19
- Last updated
- 2018-08-17
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02686294. Inclusion in this directory is not an endorsement.