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Completed

NCT Number: NCT04631874

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

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Pharmacokinetics

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital

Cheongju-si, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDFF0318, Champix

Drug

CDFF0318: Varenicline salt changed Champix: Varenicline tartrate

Primary outcomes

  1. Pharmacokinetics (AUC0-t)

    Time frame: 72 hours

    AUC0-t of "CDFF0318" and "Champix Tab. 1mg"

  2. Pharmacokinetics (Cmax)

    Time frame: 72 hours

    Cmax of "CDFF0318" and "Champix Tab. 1mg"

Secondary outcomes

  1. Safety and tolerability (Vital sign)

    Time frame: 72 hours

    Blood pressure (mmHg)

  2. Safety and tolerability (Vital sign)

    Time frame: 72 hours

    Heart rate (beats/min)

  3. Safety and tolerability (12-lead ECG)

    Time frame: 72 hours

    ventricular rate (beats/min)

  4. Safety and tolerability (12-lead ECG)

    Time frame: 72 hours

    PR interval (msec)

  5. Safety and tolerability (Laboratory tests)

    Time frame: 72 hours

    Creatinine [mg/dL]

  6. Safety and tolerability (Laboratory tests)

    Time frame: 72 hours

    AST, ALT [IU/L]

  7. Safety and tolerability (Laboratory tests)

    Time frame: 72 hours

    eGFR [mL/min/1.73m^2]

  8. Safety and tolerability (Adverse events)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

CTC Bio, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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