Clinical trial NCT04081857: A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy Subjects
Official title: A Randomized, Open-Label, Single-Dose, Crossover Study to Compare Pharmacokinetic Properties and Safety of HCP1704 and HGP1810 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health, Subjective
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Cmax of Vildagliptin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: AUClast of Vildagliptin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: Cmax of Metformin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: AUClast of Metformin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Secondary outcomes:
measure: AUCinf of Vildagliptin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: Tmax of Vildagliptin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: t1/2 of Vildagliptin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: CL/F of Vildagliptin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: Vd/F of Vildagliptin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: AUCinf of Metformin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: Tmax of Metformin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: t1/2 of Metformin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: CL/F of Metformin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
measure: Vd/F of Metformin
timeFrame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Metro hospital
Study officials:
References: