Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male Subjects
NCT ID: NCT02614352
Last Updated: 2015-11-25
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
60 participants
INTERVENTIONAL
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
NONE
Study Groups
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AG1502
Atorvastatin + Candesartan
AG1502
Candesartan + Atorvastatin
Atorvastatin + Candesartan
AG1502
Interventions
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Atorvastatin + Candesartan
AG1502
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
No
Sponsors
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Ahn-Gook Pharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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AGCA_BE_1501
Identifier Type: -
Identifier Source: org_study_id