Pharmacokinetic Drug-drug Interaction of CKD-330 and D086

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Hyperlipidemias
• Intervention / Treatment: Drug: CKD-330; Drug: CKD-330 + D086; Drug: D086

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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: CKD-330 + D086; Drug: 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: CKD-330 + D086; Drug: D086

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCτ,ss of Candesartan and Amlodipine	Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin	Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: 170DDI16017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No