Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816
- Registration Number
- NCT02554136
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 3 HGP0918 HGP0918 + HGP0816 -\> HGP0918 -\> HGP0816 Sequence 2 HGP0918 + HGP0816 HGP0816 -\> HGP0918 + HGP0816 -\> HGP0918 Sequence 1 HGP0816 HGP0918 -\> HGP0816 -\> HGP0918 + HGP0816 Sequence 1 HGP0918 + HGP0816 HGP0918 -\> HGP0816 -\> HGP0918 + HGP0816 Sequence 2 HGP0918 HGP0816 -\> HGP0918 + HGP0816 -\> HGP0918 Sequence 2 HGP0816 HGP0816 -\> HGP0918 + HGP0816 -\> HGP0918 Sequence 1 HGP0918 HGP0918 -\> HGP0816 -\> HGP0918 + HGP0816 Sequence 3 HGP0816 HGP0918 + HGP0816 -\> HGP0918 -\> HGP0816 Sequence 3 HGP0918 + HGP0816 HGP0918 + HGP0816 -\> HGP0918 -\> HGP0816 Sequence 4 HGP0918 HGP0918 -\> HGP0918 + HGP0816 -\> HGP0816 Sequence 4 HGP0816 HGP0918 -\> HGP0918 + HGP0816 -\> HGP0816 Sequence 4 HGP0918 + HGP0816 HGP0918 -\> HGP0918 + HGP0816 -\> HGP0816 Sequence 5 HGP0918 HGP0816 -\> HGP0918 -\> HGP0918 + HGP0816 Sequence 5 HGP0816 HGP0816 -\> HGP0918 -\> HGP0918 + HGP0816 Sequence 5 HGP0918 + HGP0816 HGP0816 -\> HGP0918 -\> HGP0918 + HGP0816 Sequence 6 HGP0918 HGP0918 + HGP0816 -\> HGP0816 -\> HGP0918 Sequence 6 HGP0816 HGP0918 + HGP0816 -\> HGP0816 -\> HGP0918 Sequence 6 HGP0918 + HGP0816 HGP0918 + HGP0816 -\> HGP0816 -\> HGP0918
- Primary Outcome Measures
Name Time Method baseline-corrected Cmax of HGP0918 -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) baseline-corrected AUCt of HGP0918 -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) Cmax of HGP0816 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) AUCt of HGP0816 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
- Secondary Outcome Measures
Name Time Method Cmax of HGP0918 -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) AUCt of HGP0918 -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) Tmax of HGP0918 -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) t1/2β of HGP0918 -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) AUC∞ of HGP0816 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) Tmax of HGP0816 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) t1/2β of HGP0816 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) CL/F of HGP0816 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) Vdz/F of HGP0816 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Trial Locations
- Locations (1)
Inje Busan Paik hospital
🇰🇷Busan, Korea, Republic of