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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: YHP1903; Drug: Champix

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group1; 16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8	Drug: YHP1903; YHP1903 Tab. 1mg; Drug: Champix; Comparator Champix Tab. 1mg
Other: Group2; 16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8	Drug: YHP1903; YHP1903 Tab. 1mg; Drug: Champix; Comparator Champix Tab. 1mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt	AUCt of Varenicline	0-96 hours
Cmax	Cmax of Varenicline	0-96 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Collaborators: Chonbuk National University Hospital
• Investigators: Principal Investigator: Mingul Kim, PhD, Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Pharmacokinetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: YHP1903-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No