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NCT04081857 Clinical Trial

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

Health, Subjective Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04081857
Other study ID # HM-VIME-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 3, 2019
Est. completion date August 5, 2019

Study information
Verified date September 2019
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date August 5, 2019
Est. primary completion date August 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• HGP1810
HGP1810: Vildagliptin/Metformin
• HCP1704
HCP1704: Vildagliptin/Metformin

Locations
Country Name City State
Korea, Republic of Metro hospital Anyang

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax of Vildagliptin pharmacokinetic evaluation pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Primary AUClast of Vildagliptin pharmacokinetic evaluation pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Primary Cmax of Metformin pharmacokinetic evaluation pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Primary AUClast of Metformin pharmacokinetic evaluation 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 AUCinf of Vildagliptin pharmacokinetic evaluation 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 Tmax of Vildagliptin pharmacokinetic evaluation 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 t1/2 of Vildagliptin pharmacokinetic evaluation 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 CL/F of Vildagliptin pharmacokinetic evaluation 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 Vd/F of Vildagliptin pharmacokinetic evaluation 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 AUCinf of Metformin pharmacokinetic evaluation 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 Tmax of Metformin pharmacokinetic evaluation 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 t1/2 of Metformin pharmacokinetic evaluation 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 CL/F of Metformin pharmacokinetic evaluation 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 Vd/F of Metformin pharmacokinetic evaluation pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
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