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

Phase 1

Completed

• Conditions: Health, Subjective
• Interventions: Drug: HIP1701; Drug: HGP1809

• Registration Number: NCT04087525
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-23
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Status Verified: 2019-09
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-11
• Last Update Submitted: 2019-09-11
• Study First Posted: 2019-09-12
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	HIP1701	Period 1 : Fasted state + HIP1701, Period 2 : Fasted state + HGP1809
Sequence 1	HGP1809	Period 1 : Fasted state + HIP1701, Period 2 : Fasted state + HGP1809
Sequence 2	HIP1701	Period 1 : Fasted state + HGP1809, Period 2 : Fasted state + HIP1701
Sequence 2	HGP1809	Period 1 : Fasted state + HGP1809, Period 2 : Fasted state + HIP1701

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of