A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy Subjects

Phase 1

Completed

• Conditions: Health, Subjective
• Interventions: Drug: HGP1810; Drug: HCP1704

• Registration Number: NCT04081857
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-03
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Status Verified: 2019-09
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-05
• Last Update Submitted: 2019-09-05
• Study First Posted: 2019-09-09
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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	HCP1704	Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704
Sequence 2	HGP1810	Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810
Sequence 1	HGP1810	Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704
Sequence 2	HCP1704	Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810

Primary Outcome Measures

Name	Time	Method
Cmax of Vildagliptin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
AUClast of Vildagliptin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
Cmax of Metformin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
AUClast of Metformin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation

Secondary Outcome Measures

Name	Time	Method
CL/F of Vildagliptin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
t1/2 of Vildagliptin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
AUCinf of Metformin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
t1/2 of Metformin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
CL/F of Metformin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
Vd/F of Metformin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
AUCinf of Vildagliptin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
Tmax of Vildagliptin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
Vd/F of Vildagliptin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation
Tmax of Metformin	pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour	pharmacokinetic evaluation

Trial Locations

Locations (1)

Metro hospital; 🇰🇷 Anyang, Korea, Republic of