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

A Randomized, Open-Label, Single-Dose, Crossover Study to Compare Pharmacokinetic Properties and Safety of HCP1704 and HGP1810 in Healthy Adults

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04081857
Enrollment
48
Registered
2019-09-09
Start date
2019-06-03
Completion date
2019-08-05
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Subjective

Brief summary

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

Interventions

DRUGHGP1810

HGP1810: Vildagliptin/Metformin

DRUGHCP1704

HCP1704: Vildagliptin/Metformin

Sponsors

Hanmi Pharmaceutical Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cmax of Vildagliptinpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
AUClast of Vildagliptinpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
Cmax of Metforminpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
AUClast of Metforminpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation

Secondary

MeasureTime frameDescription
Vd/F of Vildagliptinpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
AUCinf of Metforminpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
Tmax of Metforminpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
AUCinf of Vildagliptinpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
CL/F of Metforminpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
Vd/F of Metforminpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
t1/2 of Metforminpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
Tmax of Vildagliptinpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
t1/2 of Vildagliptinpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation
CL/F of Vildagliptinpre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hourpharmacokinetic evaluation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026