Pharmacokinetic Drug-drug Interaction of CKD-330 and D086

NCT03017950 | Completed Phase 1

• 1 other identifier: 170DDI16017
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension; Hyperlipidemias

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Part1 (A)

EXPERIMENTAL

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

Part1 (B)

EXPERIMENTAL

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

Part2 (A)

EXPERIMENTAL

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

Part2 (B)

EXPERIMENTAL

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

Interventions

CKD-330 DRUG

Part1 (A); Part1 (B)

D086 DRUG

Part2 (A); Part2 (B)

CKD-330 + D086 DRUG

Part1 (A); Part1 (B); Part2 (A); Part2 (B)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: December 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)