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Pharmacokinetic Drug-drug Interaction of CKD-330 and D086

Primary Purpose

Hypertension, Hyperlipidemias

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CKD-330

D086

CKD-330 + D086

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adult males age of between 19 - 45 on the day of screening.
Body mass index(BMI) between 18.0 - 29.0 kg/m^2 and weight ≥ 55kg (Body mass index (BMI) = weight (kg) / height (m)^2)
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.
Not abnormal or not clinically significant lab values.
Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion Criteria:

No history or presence of clinically significant cardiac, respiratory, neurological, endocrine, metal and renal diseases and liver and kidney diseases.
Subjects showing angioedema as an adverse reaction to ACE inhibitors
Primary Hyperaldosteronism
History or family history of myopathy
Subjects with mental diseases or drug addiction
Allergic reactions to candesartan or amlodipine or atorvastatin
Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
Hypotension(SBP ≤100mmHg or DBP≤55mnHg) or hypertension ( SNP ≥ 150mmHg, DBP ≥95mmHg) on the day of screening
Subjects who experienced gastrointestinal diseases or surgeries which can affect absorption of Investigational product
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)
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
Subjects who previously participated in other clinical trials within 90 days
Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
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)
Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
Subjects who have taken any diets affecting absorption, metabolism, distribution and excretion of investigational products (especially grapefruit juice).
Subjects who are in conditions impossible participating in the clinical trials following other laboratory tests.
Unable to use contraceptions.

Sites / Locations

Inha University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Part1 (A)

Part1 (B)

Part2 (A)

Part2 (B)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

AUCτ,ss of Candesartan and Amlodipine

AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin

Secondary Outcome Measures

Full Information

NCT ID

NCT03017950

First Posted

January 10, 2017

Last Updated

July 19, 2017

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT03017950

Brief Title

Pharmacokinetic Drug-drug Interaction of CKD-330 and D086

Official Title

Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

December 2016 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Hyperlipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part1 (A)

Arm Type

Experimental

Arm Description

Arm Title

Part1 (B)

Arm Type

Experimental

Arm Description

Arm Title

Part2 (A)

Arm Type

Experimental

Arm Description

Arm Title

Part2 (B)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

CKD-330

Intervention Type

Drug

Intervention Name(s)

D086

Intervention Type

Drug

Intervention Name(s)

CKD-330 + D086

Primary Outcome Measure Information:

Title

AUCτ,ss of Candesartan and Amlodipine

Time Frame

Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30

Title

AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin

Time Frame

Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adult males age of between 19 - 45 on the day of screening. Body mass index(BMI) between 18.0 - 29.0 kg/m^2 and weight ≥ 55kg (Body mass index (BMI) = weight (kg) / height (m)^2) 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. Not abnormal or not clinically significant lab values. Subjects who signed informed consent form with good understandings after explanations by investigators. Exclusion Criteria: No history or presence of clinically significant cardiac, respiratory, neurological, endocrine, metal and renal diseases and liver and kidney diseases. Subjects showing angioedema as an adverse reaction to ACE inhibitors Primary Hyperaldosteronism History or family history of myopathy Subjects with mental diseases or drug addiction Allergic reactions to candesartan or amlodipine or atorvastatin Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption. Hypotension(SBP ≤100mmHg or DBP≤55mnHg) or hypertension ( SNP ≥ 150mmHg, DBP ≥95mmHg) on the day of screening Subjects who experienced gastrointestinal diseases or surgeries which can affect absorption of Investigational product 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) 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 Subjects who previously participated in other clinical trials within 90 days Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days 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) Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days. Subjects who have taken any diets affecting absorption, metabolism, distribution and excretion of investigational products (especially grapefruit juice). Subjects who are in conditions impossible participating in the clinical trials following other laboratory tests. Unable to use contraceptions.

Facility Information:

Facility Name

Inha University Hospital

City

Incheon

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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Pharmacokinetic Drug-drug Interaction of CKD-330 and D086

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