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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726866
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Hypertension Drug: Sequence 1 Drug: Sequence 2 Drug: Sequence 3 Drug: Sequence 4 Drug: Sequence 5 Drug: Sequence 6 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Sequence 1
Sequence 1
Drug: Sequence 1
D326, D337 or CKD-828 for 9 days

Experimental: Sequence 2
Sequence 2
Drug: Sequence 2
D326, D337 or CKD-828 for 9 days

Experimental: Sequence 3
Sequence 3
Drug: Sequence 3
D326, D337 or CKD-828 for 9 days

Experimental: Sequence 4
Sequence 4
Drug: Sequence 4
D326, D337 or CKD-828 for 9 days

Experimental: Sequence 5
Sequence 5
Drug: Sequence 5
D326, D337 or CKD-828 for 9 days

Experimental: Sequence 6
Sequence 6
Drug: Sequence 6
D326, D337 or CKD-828 for 9 days




Primary Outcome Measures :
  1. Cmax(Maximum plasma concentration of the drug at steady state) [ Time Frame: at Day 9 ]
    PK parameters of D326, D337 and CKD-828

  2. AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) [ Time Frame: at Day 9 ]
    PK parameters of D326, D337 and CKD-828


Secondary Outcome Measures :
  1. Tmax(Time to maximum plasma concentration at steady state) [ Time Frame: at Day 9 ]
    PK parameters of D326, D337 and CKD-828

  2. t1/2(Terminal elimination half-life) [ Time Frame: at Day 9 ]
    PK parameters of D326, D337 and CKD-828



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726866


Contacts
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Contact: Jihwan Oh 82-2-6373-0953 jihwan@ckdpharm.com

Locations
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Korea, Republic of
Asan Medical Center, University of Ulsan Recruiting
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Hyeong-Seok Lim, M.D., Ph.D. Department of Clinical Pharmacology and Therapeutics / Asan Medical Center, University of Ulsan

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03726866    
Other Study ID Numbers: 186DDI18020
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chong Kun Dang Pharmaceutical:
dyslipidemias
hypertension
Drug-Drug interaction
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases