A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy Subjects

NCT ID: NCT04081857

Last Updated: 2019-09-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2019-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health, Subjective

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequence 1

Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704

Group Type EXPERIMENTAL

HGP1810

Intervention Type DRUG

HGP1810: Vildagliptin/Metformin

HCP1704

Intervention Type DRUG

HCP1704: Vildagliptin/Metformin

Sequence 2

Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810

Group Type EXPERIMENTAL

HGP1810

Intervention Type DRUG

HGP1810: Vildagliptin/Metformin

HCP1704

Intervention Type DRUG

HCP1704: Vildagliptin/Metformin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HGP1810

HGP1810: Vildagliptin/Metformin

Intervention Type DRUG

HCP1704

HCP1704: Vildagliptin/Metformin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 19\~55 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 24.9 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

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Metro hospital

Anyang, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HM-VIME-102

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.