Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects

NCT02609711 | Unknown Phase 1

• 1 other identifier: AGCA_DI_1501
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin

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

• 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

• AUClast (Atorvastatin)

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

Interventions

Candesartan cilexetil DRUG

Also known as: atorvastatin

Eligibility Criteria

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

You may qualify if:

• Adult healthy males 20 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

Study Sites (1)

Inha Univ. Hospital

Incheon, Incheon, South Korea

Location

MeSH Terms

Interventions

candesartan cilexetil; Atorvastatin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chul Woo Kim

  INHA UNIV. HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

KR (1)