A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502

NCT04018378 | Completed Phase 1 DMC

• 1 other identifier: HM-VANC-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC

  area under the plasma concentration-time curve

  0 (predose) ~ 96 hours

• Cmax

  maximum plasma concentration of the drug

  0 (predose) ~ 96 hours

Secondary Outcomes (4)

• Tmax

  0 (predose) ~ 96 hours

• T1/2

  0 (predose) ~ 96 hours

• CL/F

  0 (predose) ~ 96 hours

• Vd/F

  0 (predose) ~ 96 hours

Study Arms (2)

RT

EXPERIMENTAL

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.

Drug: varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT

TR

EXPERIMENTAL

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.

Drug: varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR

Interventions

varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT DRUG

varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.

RT

varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR DRUG

varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.

TR

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Seoul, 136-705, South Korea

Location

MeSH Terms

Interventions

Varenicline

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: an open-label, randomized, single-dose crossover clinical trial

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: January 6, 2017
• Primary Completion: May 15, 2017
• Study Completion: September 17, 2018
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)