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Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects

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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

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects
Official Title  ICMJE Not Provided
Brief Summary primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Male Subjects
Intervention  ICMJE Drug: Candesartan cilexetil
Other Name: atorvastatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 18, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609711
Other Study ID Numbers  ICMJE AGCA_DI_1501
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahn-Gook Pharmaceuticals Co.,Ltd
Study Sponsor  ICMJE Ahn-Gook Pharmaceuticals Co.,Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chul Woo Kim INHA UNIV. HOSPITAL
PRS Account Ahn-Gook Pharmaceuticals Co.,Ltd
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP