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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: YHP1903; Drug: Champix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04225052

YHP1903-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Group1

Other group

Description:

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

Treatment:

Drug: YHP1903

Drug: Champix

Group2

Other group

Description:

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

Treatment:

Drug: YHP1903

Drug: Champix