A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03826641

Enrollment

Registered

2019-02-01

Start date

2019-02-01

Completion date

2019-04-16

Last updated

2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.

Interventions

DRUGHCP1805

Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

DRUGHCP1801

Dapagliflozin/Metformin 10/1000mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Age 19\ 45 years in healthy volunteers 2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2 3. 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

1. 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 2. Subjects who judged ineligible by the investigator

Design outcomes

Primary

Measure	Time frame	Description
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
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
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
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

Secondary

Measure	Time frame	Description
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
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
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
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
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
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
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
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026