A Clinical Trial to Compare Pharmacokinetics of the "CDFF0318" and "Champix Tab. 1mg"

A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline Tartrate)" in Healthy Male Volunteers

A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline tartrate)" in Healthy Male Volunteers

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Pharmacokinetics
• Intervention / Treatment: Drug: CDFF0318, Champix

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheongju-si, Korea, Republic of
    • Chungbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects aged 19 to 45 years
• a body mass index of 18.0-30.0 kg/m2

Exclusion Criteria:

• Subjects with disease history or current disease of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, urinary system, cardiovascular system, etc.
• Subjects with a history of gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of investigational drugs
• Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing varenicline and other drugs (ketoprofen, aspirin, antibiotics, etc.)
• Subjects who have an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of the drug, or who eat food that may affect drug metabolism

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
Experimental: Sequence A(RT); Reference drug (Champix) -> washout -> test drug (CDFF0318)	Drug: CDFF0318, Champix; CDFF0318: Varenicline salt changed Champix: Varenicline tartrate
Experimental: Sequence B(TR); Test drug (CDFF0318) -> washout -> reference drug (Champix)	Drug: CDFF0318, Champix; CDFF0318: Varenicline salt changed Champix: Varenicline tartrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (AUC0-t)	AUC0-t of "CDFF0318" and "Champix Tab. 1mg"	72 hours
Pharmacokinetics (Cmax)	Cmax of "CDFF0318" and "Champix Tab. 1mg"	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability (Vital sign)	Blood pressure (mmHg)	72 hours
Safety and tolerability (Vital sign)	Heart rate (beats/min)	72 hours
Safety and tolerability (12-lead ECG)	ventricular rate (beats/min)	72 hours
Safety and tolerability (12-lead ECG)	PR interval (msec)	72 hours
Safety and tolerability (Laboratory tests)	Creatinine [mg/dL]	72 hours
Safety and tolerability (Laboratory tests)	AST, ALT [IU/L]	72 hours
Safety and tolerability (Laboratory tests)	eGFR [mL/min/1.73m^2]	72 hours
Safety and tolerability (Adverse events)	Adverse events were collected regardless of the time point when the subject complained of symptoms. Adverse events were assessed by CTCAE v5.0	72 hours

Collaborators and Investigators

• Sponsor: CTC Bio, Inc.
• Investigators: Principal Investigator: Min-Kyu Park, Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 15, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• 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: CTC-IND-CDFF0318_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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