A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects

A Randomized, Open-Label, Single-Dose, Two-way Crossover Study to Compare Pharmacokinetic Properties and Safety of HIP1701 and HGP1809 in Healthy Adults

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HIP1701 in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Health, Subjective
• Intervention / Treatment: Drug: HIP1701; Drug: HGP1809

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health system, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 19~55 years in healthy volunteers
2. BMI is more than 18.5 kg/m^2 , no more than 24.9 kg/m^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1 : Fasted state + HIP1701, Period 2 : Fasted state + HGP1809	Drug: HIP1701; Vildagliptin; Drug: HGP1809; Vildagliptin
Experimental: Sequence 2; Period 1 : Fasted state + HGP1809, Period 2 : Fasted state + HIP1701	Drug: HIP1701; Vildagliptin; Drug: HGP1809; Vildagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
AUClast of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Tmax of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
t1/2 of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
CL/F of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Vd/F of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Actual): November 27, 2018
• Study Completion (Actual): November 27, 2018

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

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

More Information

Terms related to this study

• Other Study ID Numbers: HM-VILT-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