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Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male Subjects

Phase 1
Conditions
Healthy Male Subjects
Interventions
Registration Number
NCT02614352
Lead Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
Brief Summary

Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and Atorvastatin 40mg in healthy male subjects.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Male
Target Recruitment
60
Inclusion Criteria
  • Adult healthy males 19 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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Candesartan + AtorvastatinAtorvastatin + Candesartan-
AG1502Atorvastatin + Candesartan-
AG1502AG1502-
Candesartan + AtorvastatinAG1502-
Primary Outcome Measures
NameTimeMethod
AUClast (Atorvastatin)0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours
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
Secondary Outcome Measures
NameTimeMethod

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