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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04631874
Other study ID # CTC-IND-CDFF0318_1
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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