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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631874
• Other study ID #: CTC-IND-CDFF0318_1
• Status: Completed
• Phase: Phase 1
• Start date: July 24, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: October 2020
• Source: CTC Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics
• Smoking Cessation

Intervention

Drug:
• CDFF0318, Champix
CDFF0318: Varenicline salt changed Champix: Varenicline tartrate

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si

Sponsors (1)

Lead Sponsor	Collaborator
CTC Bio, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (AUC0-t)	AUC0-t of "CDFF0318" and "Champix Tab. 1mg"	72 hours
Primary	Pharmacokinetics (Cmax)	Cmax of "CDFF0318" and "Champix Tab. 1mg"	72 hours
Secondary	Safety and tolerability (Vital sign)	Blood pressure (mmHg)	72 hours
Secondary	Safety and tolerability (Vital sign)	Heart rate (beats/min)	72 hours
Secondary	Safety and tolerability (12-lead ECG)	ventricular rate (beats/min)	72 hours
Secondary	Safety and tolerability (12-lead ECG)	PR interval (msec)	72 hours
Secondary	Safety and tolerability (Laboratory tests)	Creatinine [mg/dL]	72 hours
Secondary	Safety and tolerability (Laboratory tests)	AST, ALT [IU/L]	72 hours
Secondary	Safety and tolerability (Laboratory tests)	eGFR [mL/min/1.73m^2]	72 hours
Secondary	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