Overview

This trial is active, not recruiting.

Condition healthy male subjects
Treatment candesartan cilexetil
Phase phase 1
Sponsor Ahn-Gook Pharmaceuticals Co.,Ltd
Start date November 2015
End date March 2016
Trial size 90 participants
Trial identifier NCT02609711, AGCA_DI_1501

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Cmax (Candesartan cilexetil)
time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
Cmax (Atorvastatin)
time frame: 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours
AUClast (Candesartan cilexetil)
time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
AUClast (Atorvastatin)
time frame: 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours

Eligibility Criteria

Male participants from 19 years up to 45 years old.

Inclusion Criteria: - Adult healthy males 20 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

Additional Information

Principal investigator Chul Woo Kim
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Ahn-Gook Pharmaceuticals Co.,Ltd.