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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02614352
Other study ID # AGCA_BE_1501
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received November 24, 2015
Last updated November 24, 2015

Study information

Verified date November 2015
Source Ahn-Gook Pharmaceuticals Co.,Ltd
Contact JINHYUNG KIM
Email agpp@ahn-gook.com
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date February 2016
Accepts healthy volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
Atorvastatin + Candesartan

AG1502


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

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 AUClast (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 (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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