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Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and the Safety Between HGP1607 and HGP1501 in Healthy Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03089112
Enrollment
30
Registered
2017-03-24
Start date
2017-03-31
Completion date
2017-06-16
Last updated
2022-11-10

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

Conditions

Healthy Male Volunteers

Brief summary

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

Interventions

DRUGHGP1607

Take it once per period

DRUGHGP1501

Take it once per period

DRUGHGP1607+HGP1501

Take it once per period

Sponsors

Hanmi Pharmaceutical Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 1.age 19\ 40 years * 2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2 * 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 frame
AUClast of HGP160716, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Cmax of HGP160716, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
baseline corrected AUClast of HGP15010,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Cmax of HGP15010,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Secondary

MeasureTime frame
Cmax of HGP15010,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected AUCinf of HGP15010,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
AUCinf of HGP160716, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
baseline corrected T1/2 of HGP15010,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Tmax of HGP15010,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Tmax of HGP160716, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
T1/2 of HGP160716, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
AUClast of HGP15010,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Countries

South Korea

Outcome results

None listed

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