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Pharmacokinetic Drug-drug Interaction of CKD-330 and D086

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ClinicalTrials.gov Identifier: NCT03017950
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
The purpose of the study is examining and comparing the pharmacokinetic drug interaction and safety of both single administration and combination administration of CKD-330 and D086 to healthy male subjects

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemias Drug: CKD-330 Drug: D086 Drug: CKD-330 + D086 Phase 1

Detailed Description:

An open-label, randomized, multiple-dose, 2-sequence, 2-period, 2-treatment, crossover study

Part1: Examining how D086 affects pharmacokinetics of CKD-330. Part2: Examining how CKD-330 affects pharmacokinetics of D086.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers
Study Start Date : December 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Part1 (A)

Number of Subjects: 10

Number of days for Period 1: 8

Number of days for Period 2: 8

Number of days for wash-out between period 1 and period 2: 14

IPs for Period 1: CKD-330

IPs for Period 2: CKD-330 + D086

Drug: CKD-330
Drug: CKD-330 + D086
Experimental: Part1 (B)

Number of Subjects: 10

Number of days for Period 1: 8

Number of days for Period 2: 8

Number of days for wash-out between period 1 and period 2: 14

IPs for Period 1: CKD-330 + D086

IPs for Period 2: CKD-330

Drug: CKD-330
Drug: CKD-330 + D086
Experimental: Part2 (A)

Number of Subjects: 30

Number of days for Period 1: 8

Number of days for Period 2: 8

Number of days for wash-out between period 1 and period 2: 14

IPs for Period 1: D086

IPs for Period 2: CKD-330 + D086

Drug: D086
Drug: CKD-330 + D086
Experimental: Part2 (B)

Number of Subjects: 30

Number of days for Period 1: 8

Number of days for Period 2: 8

Number of days for wash-out between period 1 and period 2: 14

IPs for Period 1: CKD-330 + D086

IPs for Period 2: D086

Drug: D086
Drug: CKD-330 + D086



Primary Outcome Measures :
  1. AUCτ,ss of Candesartan and Amlodipine [ Time Frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30 ]
  2. AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin [ Time Frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30 ]


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult males age of between 19 - 45 on the day of screening.
  2. Body mass index(BMI) between 18.0 - 29.0 kg/m^2 and weight ≥ 55kg (Body mass index (BMI) = weight (kg) / height (m)^2)
  3. Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
  4. Not abnormal or not clinically significant lab values.
  5. Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion Criteria:

  1. No history or presence of clinically significant cardiac, respiratory, neurological, endocrine, metal and renal diseases and liver and kidney diseases.
  2. Subjects showing angioedema as an adverse reaction to ACE inhibitors
  3. Primary Hyperaldosteronism
  4. History or family history of myopathy
  5. Subjects with mental diseases or drug addiction
  6. Allergic reactions to candesartan or amlodipine or atorvastatin
  7. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
  8. Hypotension(SBP ≤100mmHg or DBP≤55mnHg) or hypertension ( SNP ≥ 150mmHg, DBP ≥95mmHg) on the day of screening
  9. Subjects who experienced gastrointestinal diseases or surgeries which can affect absorption of Investigational product
  10. Subjects with abnormal lab values at least one below

    (AST or ALT>2 fold of upper normal limit, Total bilirubin>2 fold of upper normal limit, CPK>2 fold of upper normal limit, K <3.5mEq/L or >5.5mEq/L, Estimated Glomerular filtration rate<60mL/min/1.73m2 by Modification)

  11. Continuous drinking (over 21 units/week, 1 unit= 10g=12.5mL of pure alcohol), heavy smoker(> 10 cigarettes per day) and unable to stop drinking during clinical trials
  12. Subjects who previously participated in other clinical trials within 90 days
  13. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
  14. Subjects who were administered below medications within 30 days (cyclosporin, erythromycin, clarithromycin, lopinavir, ritonavir, itraconazole, ketoconazole, rifampicin, barbiturate : theses medicines could affect absorption, metabolism, distribution and excretion of candesartan,amlodipine and atorvastatin)
  15. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
  16. Subjects who have taken any diets affecting absorption, metabolism, distribution and excretion of investigational products (especially grapefruit juice).
  17. Subjects who are in conditions impossible participating in the clinical trials following other laboratory tests.
  18. Unable to use contraceptions.

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): NCT03017950


Locations
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Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03017950     History of Changes
Other Study ID Numbers: 170DDI16017
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases