NCT03849287

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

1 month

First QC Date

February 20, 2019

Last Update Submit

February 21, 2019

Conditions

HypertensionDyslipidemias

Outcome Measures

Primary Outcomes (6)

  • AUClast of Candesartan

    Area under the plasma concentration-time curve to last concentration of Candesartan

    0 hour ~ 72 hour after drug administration

  • AUClast of Amlodipine

    Area under the plasma concentration-time curve to last concentration of Amlodipine

    0 hour ~ 72 hour after drug administration

  • AUClast of Atorvastatin

    Area under the plasma concentration-time curve to last concentration of Atorvastatin

    0 hour ~ 72 hour after drug administration

  • Cmax of Candesartan

    Maximum plasma concentration of Candesartan

    0 hour ~ 72 hour after drug administration

  • Cmax of Amlodipine

    Maximum plasma concentration of Amlodipine

    0 hour ~ 72 hour after drug administration

  • Cmax of Atorvastatin

    Maximum plasma concentration of Atorvastatin

    0 hour ~ 72 hour after drug administration

Secondary Outcomes (20)

  • AUCinf of Candesartan

    0 hour ~ 72 hour after drug administration

  • AUCinf of Amlodipine

    0 hour ~ 72 hour after drug administration

  • AUCinf of Atorvastatin

    0 hour ~ 72 hour after drug administration

  • AUCinf of 2-hydroxy atorvastatin

    0 hour ~ 72 hour after drug administration

  • Tmax of Candesartan

    0 hour ~ 72 hour after drug administration

  • +15 more secondary outcomes

Study Arms (6)

Group 1

EXPERIMENTAL

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

Drug: CKD-333, formula IDrug: CKD-333, formula IIDrug: CKD-330, D090

Group 2

EXPERIMENTAL

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

Drug: CKD-333, formula IDrug: CKD-333, formula IIDrug: CKD-330, D090

Group 3

EXPERIMENTAL

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

Drug: CKD-333, formula IDrug: CKD-333, formula IIDrug: CKD-330, D090

Group 4

EXPERIMENTAL

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

Drug: CKD-333, formula IDrug: CKD-333, formula IIDrug: CKD-330, D090

Group 5

EXPERIMENTAL

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

Drug: CKD-333, formula IDrug: CKD-333, formula IIDrug: CKD-330, D090

Group 6

EXPERIMENTAL

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

Drug: CKD-333, formula IDrug: CKD-333, formula IIDrug: CKD-330, D090

Interventions

CKD-333, formula IDRUG

Test drug

Group 1Group 2Group 3Group 4Group 5Group 6
CKD-333, formula IIDRUG

Test drug

Group 1Group 2Group 3Group 4Group 5Group 6
CKD-330, D090DRUG

Reference Drug

Group 1Group 2Group 3Group 4Group 5Group 6

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Saint Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Seunghun Han, Ph.D.

    Department of Clinical Pharmacology, Seoul ST.Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seunghun Han, Ph.D.

CONTACT

+82-2-2258-7326waystolove@catholic.ac.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 21, 2019

Study Start

February 25, 2019

Primary Completion

March 29, 2019

Study Completion

April 6, 2019

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)