A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects

NCT ID: NCT03726866

Last Updated: 2018-11-01

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2019-01-15

Brief Summary

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

Detailed Description

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Conditions

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Dyslipidemias Hypertension

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

Sequence 1

Group Type EXPERIMENTAL

Sequence 1

Intervention Type DRUG

D326, D337 or CKD-828 for 9 days

Sequence 2

Sequence 2

Group Type EXPERIMENTAL

Sequence 2

Intervention Type DRUG

D326, D337 or CKD-828 for 9 days

Sequence 3

Sequence 3

Group Type EXPERIMENTAL

Sequence 3

Intervention Type DRUG

D326, D337 or CKD-828 for 9 days

Sequence 4

Sequence 4

Group Type EXPERIMENTAL

Sequence 4

Intervention Type DRUG

D326, D337 or CKD-828 for 9 days

Sequence 5

Sequence 5

Group Type EXPERIMENTAL

Sequence 5

Intervention Type DRUG

D326, D337 or CKD-828 for 9 days

Sequence 6

Sequence 6

Group Type EXPERIMENTAL

Sequence 6

Intervention Type DRUG

D326, D337 or CKD-828 for 9 days

Interventions

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Sequence 1

D326, D337 or CKD-828 for 9 days

Intervention Type DRUG

Sequence 2

D326, D337 or CKD-828 for 9 days

Intervention Type DRUG

Sequence 3

D326, D337 or CKD-828 for 9 days

Intervention Type DRUG

Sequence 4

D326, D337 or CKD-828 for 9 days

Intervention Type DRUG

Sequence 5

D326, D337 or CKD-828 for 9 days

Intervention Type DRUG

Sequence 6

D326, D337 or CKD-828 for 9 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy volunteers aged between ≥ 19 and ≤ 40 years old
2. Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
3. 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
4. Subject who agree not to provide sperm
5. Subject who voluntarily agree to participate in this study

Exclusion Criteria

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

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyeong-Seok Lim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Asan Medical Center, University of Ulsan

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jihwan Oh

Role: CONTACT

82-2-6373-0953

Other Identifiers

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186DDI18020

Identifier Type: -

Identifier Source: org_study_id

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