CompletedNCT02554136Updated Sep 18, 2015

Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816

A Phase 1 interventional study of HGP0918 and HGP0816 in Healthy, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-18.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 19 Years to 55 Years
Sex: All

Study summary

The investigators investigate the potential pharmacokinetic drug-drug interaction between HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and both together in a 3 period repeatedly

Conditions studied

Healthy

In context

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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
Healthy male volunteers, aged 19 to 55 years.
The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2

Exclusion criteria

Exclusion Criteria:

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
Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
Somenone has a declined kidney function and his eGFR \< 60mL/min/1.73m2

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 36 participants (actual)

Study arms

Experimental
Sequence 1
HGP0918 -\> HGP0816 -\> HGP0918 + HGP0816
Drug: HGP0918 · Drug: HGP0816 · Drug: HGP0918 + HGP0816
Experimental
Sequence 2
HGP0816 -\> HGP0918 + HGP0816 -\> HGP0918
Drug: HGP0918 · Drug: HGP0816 · Drug: HGP0918 + HGP0816
Experimental
Sequence 3
HGP0918 + HGP0816 -\> HGP0918 -\> HGP0816
Drug: HGP0918 · Drug: HGP0816 · Drug: HGP0918 + HGP0816
Experimental
Sequence 4
HGP0918 -\> HGP0918 + HGP0816 -\> HGP0816
Drug: HGP0918 · Drug: HGP0816 · Drug: HGP0918 + HGP0816
Experimental
Sequence 5
HGP0816 -\> HGP0918 -\> HGP0918 + HGP0816
Drug: HGP0918 · Drug: HGP0816 · Drug: HGP0918 + HGP0816
Experimental
Sequence 6
HGP0918 + HGP0816 -\> HGP0816 -\> HGP0918
Drug: HGP0918 · Drug: HGP0816 · Drug: HGP0918 + HGP0816

Interventions

DrugHGP0918
DrugHGP0816
DrugHGP0918 + HGP0816

What researchers measure

Primary outcomes

baseline-corrected Cmax of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
baseline-corrected AUCt of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
Cmax of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
AUCt of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Secondary outcomes

Cmax of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
AUCt of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
Tmax of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
t1/2β of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
AUC∞ of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Tmax of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
t1/2β of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
CL/F of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Vdz/F of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Study locations

1 site

Inje Busan Paik hospital
Busan, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02554136
Lead sponsor: Hanmi Pharmaceutical Company Limited
Responsible party: Sponsor
First posted: Sep 18, 2015
Start date: Jul 2015
Primary completion: Aug 2015
Completion: Aug 2015
Last update: Sep 18, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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