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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-04-16

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

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

Group Type EXPERIMENTAL

HCP1805

Intervention Type DRUG

Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

HCP1801

Intervention Type DRUG

Dapagliflozin/Metformin 10/1000mg

Sequence 2

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

Group Type EXPERIMENTAL

HCP1805

Intervention Type DRUG

Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

HCP1801

Intervention Type DRUG

Dapagliflozin/Metformin 10/1000mg

Sequence 3

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

Group Type EXPERIMENTAL

HCP1805

Intervention Type DRUG

Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

HCP1801

Intervention Type DRUG

Dapagliflozin/Metformin 10/1000mg

Sequence 4

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

Group Type EXPERIMENTAL

HCP1805

Intervention Type DRUG

Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

HCP1801

Intervention Type DRUG

Dapagliflozin/Metformin 10/1000mg

Interventions

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HCP1805

Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

Intervention Type DRUG

HCP1801

Dapagliflozin/Metformin 10/1000mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes