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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: YHP1903; Drug: Champix

• Registration Number: NCT04225052
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study Start: 2019-12-19
• Status Verified: 2020-01
• Primary Completion: 2020-01-08
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Completion: 2020-01-14
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group2	YHP1903	16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8
Group2	Champix	16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8
Group1	YHP1903	16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8
Group1	Champix	16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8

Primary Outcome Measures

Name	Time	Method
AUCt	0-96 hours	AUCt of Varenicline
Cmax	0-96 hours	Cmax of Varenicline

Secondary Outcome Measures

Name	Time	Method
AUCinf	0-96 hours	AUCinf of Varenicline
Tmax	0-96 hours	Tmax of Varenicline
t1/2	0-96 hours	t1/2 of Varenicline

Trial Locations

Locations (1)

Chonbuk national university hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of