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

NCT02614352 | Unknown Phase 1

• 1 other identifier: AGCA_BE_1501
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (4)

• Cmax (candesartan cilexetil)

  0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours

• AUClast (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 (Atorvastatin)

  0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours

Study Arms (2)

AG1502

EXPERIMENTAL

Drug: Atorvastatin + Candesartan; Drug: AG1502

Candesartan + Atorvastatin

ACTIVE COMPARATOR

Drug: Atorvastatin + Candesartan; Drug: AG1502

Interventions

Atorvastatin + Candesartan DRUG

AG1502; Candesartan + Atorvastatin

AG1502 DRUG

AG1502; Candesartan + Atorvastatin

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Age Groups: Adult (18-64)

You may qualify if:

• Adult healthy males 19 to 45 years at screening.
• BMI 18-29 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

MeSH Terms

Interventions

Atorvastatin; candesartan

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

JINHYUNG KIM

CONTACT

agpp@ahn-gook.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 25, 2015
• Primary Completion: February 1, 2016
• Last Updated: November 25, 2015

Record last verified: 2015-11