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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225052
• Other study ID #: YHP1903-101
• Status: Completed
• Phase: Phase 1
• Start date: December 19, 2019
• Est. completion date: January 14, 2020

Study information

• Verified date: January 2020
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 14, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• YHP1903
YHP1903 Tab. 1mg
• Champix
Comparator Champix Tab. 1mg

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk national university hospital	Jeonju	Jeollabuk-do

Sponsors (2)

Lead Sponsor	Collaborator
Yuhan Corporation	Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt	AUCt of Varenicline	0-96 hours
Primary	Cmax	Cmax of Varenicline	0-96 hours
Secondary	AUCinf	AUCinf of Varenicline	0-96 hours
Secondary	Tmax	Tmax of Varenicline	0-96 hours
Secondary	t1/2	t1/2 of Varenicline	0-96 hours