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

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502 in Healthy Male Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT; Drug: varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 136-705
    • Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy volunteers aged between ≥20 and ≤45 years old
2. Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2
3. Subject who voluntarily agrees to participate in this study and signs the informed consent form.

Exclusion Criteria:

1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder.
2. With symptoms indicating acute illness within 28 days prior to the first IP administration.
3. Any medical history that may affect drug absorption, distribution, metabolism, and excretion.
4. Any clinically significant activity of chronic medical illness.
5. 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).
6. Positive blood tests for HBs Ag, anti-HCV Ab, anti-HIV Ab, or VDRL.
7. 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.
8. Inability to take standard hospital diet.
9. 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.
10. Exposure to any investigational drug or placebo within 90 days prior to the last IP administration.
11. Subjects with excessive caffeine intake (more than 5 cups/day), heavy or regular alcohol intake (more than 210 g/week).
12. Any use of tobacco or nicotine within three months.
13. Subjects rejected to use clinically effective contraceptive methods during the study period.
14. Subjects having been deemed inappropriate for the trial as determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT; varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.
EXPERIMENTAL: 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.	Drug: varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR; varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	area under the plasma concentration-time curve	0 (predose) ~ 96 hours
Cmax	maximum plasma concentration of the drug	0 (predose) ~ 96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	time to maximum plasma concentration	0 (predose) ~ 96 hours
T1/2	terminal elimination half-life	0 (predose) ~ 96 hours
CL/F	apparent total body clearance of the drug from plasma	0 (predose) ~ 96 hours
Vd/F	apparent volume of distribution	0 (predose) ~ 96 hours

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2017
• Primary Completion (ACTUAL): May 15, 2017
• Study Completion (ACTUAL): September 17, 2018

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: HM-VANC-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No