Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects

primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin

Study Overview

• Status: Unknown
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: Candesartan cilexetil

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha Univ. Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Adult healthy males 20 to 45 years at screening.
• BMI 18-29 kg/m2

Exclusion Criteria:

• History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease
• Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin
• Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
• Gastrointestinal disease affected the absorption of medications
• Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
• AST or ALT > 2 x normal range
• Total bilirubin > 2.0 mg/dl
• CK > 2 x normal range
• eGFR < 60 mL/min/1.73m2
• Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study
• Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study
• Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
• Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
• Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin
• Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days
• History of drug abuse
• Genetic neuromuscular disorder or family history of neuromuscular disorder
• Unusual diet affected the absorption, distribution, metabolism, excretion of medications
• Subjects deemed ineligible by investigator based on other reasons

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (Candesartan cilexetil)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
Cmax (Atorvastatin)	0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours
AUClast (Candesartan cilexetil)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
AUClast (Atorvastatin)	0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours

Collaborators and Investigators

• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Chul Woo Kim, Inha Univ. Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Atorvastatin; Candesartan; Candesartan cilexetil
• Other Study ID Numbers: AGCA_DI_1501