Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- AUCτ,ss of Candesartan and Amlodipine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: CKD-330 (Drug)
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
Intervention: CKD-330 + D086 (Drug)
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
Intervention: CKD-330 (Drug)
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
Intervention: CKD-330 + D086 (Drug)
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
Intervention: D086 (Drug)
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
Intervention: CKD-330 + D086 (Drug)
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
Intervention: D086 (Drug)
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
Intervention: CKD-330 + D086 (Drug)
Outcomes
Primary Outcomes
AUCτ,ss of Candesartan and Amlodipine
Time Frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin
Time Frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
Secondary Outcomes
No secondary outcomes reported