Clinical Trial to Evaluate the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-19

Study Completion Date

2020-01-14

Brief Summary

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A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers

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Detailed Description

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32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1903" by cross-over design on day1, 8.

Subjects in group 2 will be administered "YHP1903" and "comparator" by cross-over design on day1, 8.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group1

16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8

Group Type OTHER

YHP1903

Intervention Type DRUG

YHP1903 Tab. 1mg

Champix

Intervention Type DRUG

Comparator Champix Tab. 1mg

Group2

16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8

Group Type OTHER

YHP1903

Intervention Type DRUG

YHP1903 Tab. 1mg

Champix

Intervention Type DRUG

Comparator Champix Tab. 1mg

Interventions

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YHP1903

YHP1903 Tab. 1mg

Intervention Type DRUG

Champix

Comparator Champix Tab. 1mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening
3. Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion Criteria

1. History of clinically significant disease
2. Sitting blood pressure meeting the following criteria at screening:

* 140 ≤ systolic blood pressure ≤90 (mmHg)
* 90 ≤ diastolic blood pressure ≤ 60 (mmHg)
3. Have AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit or Total bilirubin \> 2.0 mg/dl at the time of screening
4. Volunteers considered not eligible for the clinical trial by the investigator
5. Administration of other investigational products within 6 month prior to the first dosing.

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes