Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HGP0816; Drug: HGP0918 + HGP0816; Drug: HGP0918

Study type: Interventional

Funder types: Industry

Identifiers

NCT02554136

HM-ROMA-105

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Sequence 1

Experimental group

Description:

HGP0918 -\> HGP0816 -\> HGP0918 + HGP0816

Treatment:

Drug: HGP0816

Drug: HGP0918 + HGP0816

Drug: HGP0918

Sequence 2

Experimental group

Description:

HGP0816 -\> HGP0918 + HGP0816 -\> HGP0918

Treatment:

Drug: HGP0816

Drug: HGP0918 + HGP0816

Drug: HGP0918

Sequence 3

Experimental group

Description:

HGP0918 + HGP0816 -\> HGP0918 -\> HGP0816

Treatment:

Drug: HGP0816

Drug: HGP0918 + HGP0816

Drug: HGP0918

Sequence 4

Experimental group

Description:

HGP0918 -\> HGP0918 + HGP0816 -\> HGP0816

Treatment:

Drug: HGP0816

Drug: HGP0918 + HGP0816

Drug: HGP0918

Sequence 5

Experimental group

Description:

HGP0816 -\> HGP0918 -\> HGP0918 + HGP0816

Treatment:

Drug: HGP0816

Drug: HGP0918 + HGP0816

Drug: HGP0918

Sequence 6

Experimental group

Description:

HGP0918 + HGP0816 -\> HGP0816 -\> HGP0918

Treatment:

Drug: HGP0816

Drug: HGP0918 + HGP0816

Drug: HGP0918