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

A

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

Trial contacts and locations

0

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Central trial contact

JINHYUNG KIM

Data sourced from clinicaltrials.gov

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