NCT03726866

Brief Summary

To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.

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
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

August 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

October 30, 2018

Last Update Submit

October 30, 2018

Conditions

DyslipidemiasHypertension

Keywords

dyslipidemiashypertensionDrug-Drug interaction

Outcome Measures

Primary Outcomes (2)

  • Cmax(Maximum plasma concentration of the drug at steady state)

    PK parameters of D326, D337 and CKD-828

    at Day 9

  • AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)

    PK parameters of D326, D337 and CKD-828

    at Day 9

Secondary Outcomes (2)

  • Tmax(Time to maximum plasma concentration at steady state)

    at Day 9

  • t1/2(Terminal elimination half-life)

    at Day 9

Study Arms (6)

Sequence 1

EXPERIMENTAL

Sequence 1

Drug: Sequence 1

Sequence 2

EXPERIMENTAL

Sequence 2

Drug: Sequence 2

Sequence 3

EXPERIMENTAL

Sequence 3

Drug: Sequence 3

Sequence 4

EXPERIMENTAL

Sequence 4

Drug: Sequence 4

Sequence 5

EXPERIMENTAL

Sequence 5

Drug: Sequence 5

Sequence 6

EXPERIMENTAL

Sequence 6

Drug: Sequence 6

Interventions

Sequence 1DRUG

D326, D337 or CKD-828 for 9 days

Sequence 1
Sequence 2DRUG

D326, D337 or CKD-828 for 9 days

Sequence 2
Sequence 3DRUG

D326, D337 or CKD-828 for 9 days

Sequence 3
Sequence 4DRUG

D326, D337 or CKD-828 for 9 days

Sequence 4
Sequence 5DRUG

D326, D337 or CKD-828 for 9 days

Sequence 5
Sequence 6DRUG

D326, D337 or CKD-828 for 9 days

Sequence 6

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers aged between ≥ 19 and ≤ 40 years old
  • Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
  • Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
  • Subject who agree not to provide sperm
  • Subject who voluntarily agree to participate in this study

You may not qualify if:

  • Any medical history that may affect drug absorption, distribution, metabolism and excretion
  • Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
  • Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
  • Subject who have received other clinical trial drugs within 90 days prior to the screening visit
  • Any clinically significant active chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center, University of Ulsan

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

DyslipidemiasHypertension

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hyeong-Seok Lim, M.D., Ph.D.

    Department of Clinical Pharmacology and Therapeutics / Asan Medical Center, University of Ulsan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihwan Oh

CONTACT

82-2-6373-0953jihwan@ckdpharm.com

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

October 30, 2018

First Posted

November 1, 2018

Study Start

August 31, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

November 1, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)