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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HCP1805; Drug: HCP1801

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf 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
Tmax 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
t1/2 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
CL/F 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
Vd/F 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
AUCinf 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
Tmax 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
t1/2 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
CL/F 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
Vd/F 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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): March 25, 2019
• Study Completion (Actual): April 16, 2019

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HM-DAME-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No