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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02609711
Other study ID # AGCA_DI_1501
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received November 18, 2015
Last updated November 18, 2015
Start date November 2015

Study information

Verified date November 2015
Source Ahn-Gook Pharmaceuticals Co.,Ltd
Contact n/a
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Candesartan cilexetil


Locations

Country Name City State
Korea, Republic of Inha Univ. Hospital Incheon

Sponsors (1)

Lead Sponsor Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax (Candesartan cilexetil) 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours No
Primary Cmax (Atorvastatin) 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours No
Primary AUClast (Candesartan cilexetil) 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours No
Primary AUClast (Atorvastatin) 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours No
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