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Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609711
Recruitment Status : Unknown
Verified November 2015 by Ahn-Gook Pharmaceuticals Co.,Ltd.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Ahn-Gook Pharmaceuticals Co.,Ltd

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

Condition or disease Intervention/treatment Phase
Healthy Male Subjects Drug: Candesartan cilexetil Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Candesartan cilexetil
    Other Name: atorvastatin


Primary Outcome Measures :
  1. Cmax (Candesartan cilexetil) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours ]
  2. 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 ]
  3. AUClast (Candesartan cilexetil) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours ]
  4. 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 ]


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609711


Locations
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Korea, Republic of
Inha Univ. Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Ahn-Gook Pharmaceuticals Co.,Ltd
Investigators
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Principal Investigator: Chul Woo Kim INHA UNIV. HOSPITAL
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Responsible Party: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT02609711    
Other Study ID Numbers: AGCA_DI_1501
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Candesartan
Candesartan cilexetil
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists