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

Phase 1

Completed

• Conditions: Smoking Cessation; Pharmacokinetics
• Interventions: Drug: CDFF0318, Champix

• Registration Number: NCT04631874
• Lead Sponsor: CTC Bio, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-24
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-15
• Last Update Submitted: 2020-11-15
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B(TR)	CDFF0318, Champix	Test drug (CDFF0318) -\> washout -\> reference drug (Champix)
Sequence A(RT)	CDFF0318, Champix	Reference drug (Champix) -\> washout -\> test drug (CDFF0318)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (AUC0-t)	72 hours	AUC0-t of "CDFF0318" and "Champix Tab. 1mg"
Pharmacokinetics (Cmax)	72 hours	Cmax of "CDFF0318" and "Champix Tab. 1mg"

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability (Adverse events)	72 hours	Adverse events were collected regardless of the time point when the subject complained of symptoms.; Adverse events were assessed by CTCAE v5.0
Safety and tolerability (Vital sign)	72 hours	Heart rate (beats/min)
Safety and tolerability (Laboratory tests)	72 hours	eGFR \[mL/min/1.73m\^2\]
Safety and tolerability (12-lead ECG)	72 hours	PR interval (msec)

Trial Locations

Locations (1)

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Korea, Republic of