A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects
- Registration Number
- NCT03826641
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
Inclusion Criteria
- Age 19~45 years in healthy volunteers
- BMI is more than 18.5 kg/m^2 , no more than 29.9 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 3 HCP1801 Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801 Sequence 4 HCP1801 Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805 Sequence 2 HCP1801 Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805 Sequence 1 HCP1801 Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801 Sequence 4 HCP1805 Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805 Sequence 1 HCP1805 Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801 Sequence 3 HCP1805 Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801 Sequence 2 HCP1805 Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805
- Primary Outcome Measures
Name Time Method AUClast of Dapagliflozin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
AUClast of Metformin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
Cmax of Dapagliflozin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
Cmax of Metformin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
- Secondary Outcome Measures
Name Time Method Tmax of Dapagliflozin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
AUCinf of Dapagliflozin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
t1/2 of Dapagliflozin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
AUCinf of Metformin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
CL/F of Dapagliflozin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
Vd/F of Dapagliflozin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
Tmax of Metformin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
CL/F of Metformin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
Vd/F of Metformin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
t1/2 of Metformin pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour pharmacokinetic evaluation
Trial Locations
- Locations (1)
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of