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

NCT ID: NCT04018378

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-06
• Study Completion Date: 2018-09-17

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji-Young Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HM-VANC-101

Identifier Type: -

Identifier Source: org_study_id