An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- HCP1805
- Conditions
- Healthy
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- AUClast of Dapagliflozin
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.
Investigators
Eligibility Criteria
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
Arms & Interventions
Sequence 1
Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801
Intervention: HCP1805
Sequence 1
Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801
Intervention: HCP1801
Sequence 2
Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805
Intervention: HCP1805
Sequence 2
Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805
Intervention: HCP1801
Sequence 3
Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801
Intervention: HCP1805
Sequence 3
Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801
Intervention: HCP1801
Sequence 4
Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805
Intervention: HCP1805
Sequence 4
Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805
Intervention: HCP1801
Outcomes
Primary Outcomes
AUClast of Dapagliflozin
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)