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

Ahn-Gook Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: AG1502; Drug: Atorvastatin + Candesartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02614352

AGCA_BE_1501

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

AG1502

Experimental group

Treatment:

Drug: Atorvastatin + Candesartan

Drug: AG1502

Candesartan + Atorvastatin

Active Comparator group

Treatment:

Drug: Atorvastatin + Candesartan

Drug: AG1502