Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2019-04-06

Brief Summary

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

The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics and Safety Profile of CKD-333

NCT03659149

Hypertension Dyslipidemias

COMPLETED PHASE1

Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

NCT04478097

Cardiovascular Disease

UNKNOWN PHASE1

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers

NCT04019743

Hypertension Dyslipidemias

COMPLETED PHASE1

Compare the Pharmacokinetics and Safety of CKD-391

NCT04354987

Hyperlipidemias

COMPLETED PHASE1

A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

NCT03920579

Hypertension Dyslipidemias

UNKNOWN PHASE1

Detailed Description

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

An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D090 in healthy male adults

Conditions

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

Hypertension Dyslipidemias

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.

Group 1

* Period 1: CKD-333, formula I
* Period 2: CKD-333, formula II
* Period 3: CKD-330, D090

Group Type EXPERIMENTAL

CKD-333, formula I

Intervention Type DRUG

Test drug

CKD-333, formula II

Intervention Type DRUG

Test drug

CKD-330, D090

Intervention Type DRUG

Reference Drug

Group 2

* Period 1: CKD-333, formula I
* Period 2: CKD-330, D090
* Period 3: CKD-333, formula II

Group Type EXPERIMENTAL

CKD-333, formula I

Intervention Type DRUG

Test drug

CKD-333, formula II

Intervention Type DRUG

Test drug

CKD-330, D090

Intervention Type DRUG

Reference Drug

Group 3

* Period 1: CKD-333, formula II
* Period 2: CKD-330, D090
* Period 3: CKD-333, formula I

Group Type EXPERIMENTAL

CKD-333, formula I

Intervention Type DRUG

Test drug

CKD-333, formula II

Intervention Type DRUG

Test drug

CKD-330, D090

Intervention Type DRUG

Reference Drug

Group 4

* Period 1: CKD-333, formula II
* Period 2: CKD-333, formula I
* Period 3: CKD-330, D090

Group Type EXPERIMENTAL

CKD-333, formula I

Intervention Type DRUG

Test drug

CKD-333, formula II

Intervention Type DRUG

Test drug

CKD-330, D090

Intervention Type DRUG

Reference Drug

Group 5

* Period 1: CKD-330, D090
* Period 2: CKD-333, formula I
* Period 3: CKD-333, formula II

Group Type EXPERIMENTAL

CKD-333, formula I

Intervention Type DRUG

Test drug

CKD-333, formula II

Intervention Type DRUG

Test drug

CKD-330, D090

Intervention Type DRUG

Reference Drug

Group 6

* Period 1: CKD-330, D090
* Period 2: CKD-333, formula II
* Period 3: CKD-333, formula I

Group Type EXPERIMENTAL

CKD-333, formula I

Intervention Type DRUG

Test drug

CKD-333, formula II

Intervention Type DRUG

Test drug

CKD-330, D090

Intervention Type DRUG

Reference Drug

Interventions

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

CKD-333, formula I

Test drug

Intervention Type DRUG

CKD-333, formula II

Test drug

Intervention Type DRUG

CKD-330, D090

Reference Drug

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. Healthy male adults aged 19 to 45 years
2. Body weight more than 50kg and within ideal body weight ±20%
3. signed informed consent form

Exclusion Criteria

1. Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
2. Have a gastrointestinal disease history that can effect drug absorption or surgery
3. Systolic Blood pressure≥140mmHg or Systolic Blood pressure\<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure\<60mmHg

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes