Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects
NCT ID: NCT02609711
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
90 participants
INTERVENTIONAL
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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Candesartan cilexetil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 18-29 kg/m2
Exclusion Criteria
* 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
19 Years
45 Years
MALE
Yes
Sponsors
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Ahn-Gook Pharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Chul Woo Kim
Role: PRINCIPAL_INVESTIGATOR
INHA UNIV. HOSPITAL
Locations
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Inha Univ. Hospital
Incheon, Incheon, South Korea
Countries
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Other Identifiers
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AGCA_DI_1501
Identifier Type: -
Identifier Source: org_study_id