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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT03826641

Collaborator

(none)

Enrollment

Location

Arms

2.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HCP1805 Drug: HCP1801	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Mar 25, 2019

Actual Study Completion Date :

Apr 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801	Drug: HCP1805 Dapagliflozin/Metformin (Xigduo XR) 10/1000mg Drug: HCP1801 Dapagliflozin/Metformin 10/1000mg
Experimental: Sequence 2 Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805	Drug: HCP1805 Dapagliflozin/Metformin (Xigduo XR) 10/1000mg Drug: HCP1801 Dapagliflozin/Metformin 10/1000mg
Experimental: Sequence 3 Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801	Drug: HCP1805 Dapagliflozin/Metformin (Xigduo XR) 10/1000mg Drug: HCP1801 Dapagliflozin/Metformin 10/1000mg
Experimental: Sequence 4 Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805	Drug: HCP1805 Dapagliflozin/Metformin (Xigduo XR) 10/1000mg Drug: HCP1801 Dapagliflozin/Metformin 10/1000mg

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyungpook National University Hospital	Daegu		Korea, Republic of

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT03826641

Other Study ID Numbers:

HM-DAME-101

First Posted:

Feb 1, 2019

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 14, 2022