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

A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04225052

Enrollment

Registered

2020-01-13

Start date

2019-12-19

Completion date

2020-01-14

Last updated

2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Pharmacokinetics

Brief summary

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

Detailed description

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.

Interventions

DRUGYHP1903

YHP1903 Tab. 1mg

DRUGChampix

Comparator Champix Tab. 1mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Cmax	0-96 hours	Cmax of Varenicline
AUCt	0-96 hours	AUCt of Varenicline

Secondary

Measure	Time frame	Description
AUCinf	0-96 hours	AUCinf of Varenicline
Tmax	0-96 hours	Tmax of Varenicline
t1/2	0-96 hours	t1/2 of Varenicline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026