A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04018378
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Healthy volunteers aged between ≥20 and ≤45 years old
- Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2
- Subject who voluntarily agrees to participate in this study and signs the informed consent form.
Exclusion Criteria
- History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder.
- With symptoms indicating acute illness within 28 days prior to the first IP administration.
- Any medical history that may affect drug absorption, distribution, metabolism, and excretion.
- Any clinically significant activity of chronic medical illness.
- History of any clinically significant allergic reaction including induced by varenicline (However, mild allergic rhinitis or allergic dermatitis which do not require medication could be included).
- Positive blood tests for HBs Ag, anti-HCV Ab, anti-HIV Ab, or VDRL.
- Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration or use of over-the-counter medications (OTC) and vitamin products within 10 days prior to study drug administration.
- Inability to take standard hospital diet.
- Donation of blood within 60 days prior to study drug administration or apheresis within 20 days, or blood transfusion within 30 days prior to the first IP administration.
- Exposure to any investigational drug or placebo within 90 days prior to the last IP administration.
- Subjects with excessive caffeine intake (more than 5 cups/day), heavy or regular alcohol intake (more than 210 g/week).
- Any use of tobacco or nicotine within three months.
- Subjects rejected to use clinically effective contraceptive methods during the study period.
- Subjects having been deemed inappropriate for the trial as determined by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TR varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR period 1: HIP1502 1mg (test drug, T) will be administered once orally. period 2: HGP1604 1mg (reference drug, R) will be administered once orally after 14 days of the washout period. RT varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT period 1: HGP1604 1mg (reference drug, R) will be administered once orally. period 2: HIP1502 1mg (test drug, T) will be administered once orally after 14 days of the washout period.
- Primary Outcome Measures
Name Time Method Cmax 0 (predose) ~ 96 hours maximum plasma concentration of the drug
AUC 0 (predose) ~ 96 hours area under the plasma concentration-time curve
- Secondary Outcome Measures
Name Time Method Tmax 0 (predose) ~ 96 hours time to maximum plasma concentration
Vd/F 0 (predose) ~ 96 hours apparent volume of distribution
CL/F 0 (predose) ~ 96 hours apparent total body clearance of the drug from plasma
T1/2 0 (predose) ~ 96 hours terminal elimination half-life
Trial Locations
- Locations (1)
Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
🇰🇷Seoul, Korea, Republic of