NCT03826641

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

January 28, 2019

Last Update Submit

July 12, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Cmax of Dapagliflozin

    pharmacokinetic evaluation

    pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

  • AUClast of Dapagliflozin

    pharmacokinetic evaluation

    pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

  • Cmax of Metformin

    pharmacokinetic evaluation

    pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

  • AUClast of Metformin

    pharmacokinetic evaluation

    pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

Secondary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • +5 more secondary outcomes

Study Arms (4)

Sequence 1

EXPERIMENTAL

Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801

Drug: HCP1805Drug: HCP1801

Sequence 2

EXPERIMENTAL

Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805

Drug: HCP1805Drug: HCP1801

Sequence 3

EXPERIMENTAL

Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801

Drug: HCP1805Drug: HCP1801

Sequence 4

EXPERIMENTAL

Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805

Drug: HCP1805Drug: HCP1801

Interventions

HCP1805DRUG

Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

Sequence 1Sequence 2Sequence 3Sequence 4
HCP1801DRUG

Dapagliflozin/Metformin 10/1000mg

Sequence 1Sequence 2Sequence 3Sequence 4

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 1, 2019

Study Start

February 1, 2019

Primary Completion

March 25, 2019

Study Completion

April 16, 2019

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)