A Randomized, Open-Label, Single-Dose, Crossover Study to Compare Pharmacokinetic Properties and Safety of HCP1704 and HGP1810 in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- HGP1810
- Conditions
- Health, Subjective
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Cmax of Vildagliptin
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 19\~55 years in healthy volunteers
- •BMI is more than 18.5 kg/m\^2 , no more than 24.9 kg/m\^2
- •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
- •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
- •Subjects who judged ineligible by the investigator
Arms & Interventions
Sequence 1
Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704
Intervention: HGP1810
Sequence 1
Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704
Intervention: HCP1704
Sequence 2
Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810
Intervention: HGP1810
Sequence 2
Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810
Intervention: HCP1704
Outcomes
Primary Outcomes
Cmax of Vildagliptin
Time Frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
pharmacokinetic evaluation
AUClast of Vildagliptin
Time Frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
pharmacokinetic evaluation
Cmax of Metformin
Time Frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
pharmacokinetic evaluation
AUClast of Metformin
Time Frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
pharmacokinetic evaluation
Secondary Outcomes
- CL/F of Vildagliptin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)
- t1/2 of Vildagliptin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)
- AUCinf of Metformin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)
- t1/2 of Metformin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)
- CL/F of Metformin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)
- Vd/F of Metformin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)
- AUCinf of Vildagliptin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)
- Tmax of Vildagliptin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)
- Vd/F of Vildagliptin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)
- Tmax of Metformin(pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour)