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

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Hypertension; Dyslipidemias

Treatments: Drug: Sequence 3; Drug: Sequence 5; Drug: Sequence 2; Drug: Sequence 4; Drug: Sequence 1; Drug: Sequence 6

Study type: Interventional

Funder types: Industry

Identifiers

NCT03726866

186DDI18020

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Sequence 1

Treatment:

Drug: Sequence 1

Sequence 2

Experimental group

Description:

Sequence 2

Treatment:

Drug: Sequence 2

Sequence 3

Experimental group

Description:

Sequence 3

Treatment:

Drug: Sequence 3

Sequence 4

Experimental group

Description:

Sequence 4

Treatment:

Drug: Sequence 4

Sequence 5

Experimental group

Description:

Sequence 5

Treatment:

Drug: Sequence 5

Sequence 6

Experimental group

Description:

Sequence 6

Treatment:

Drug: Sequence 6