- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02614352
Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male Subjects
November 24, 2015 updated by: Ahn-Gook Pharmaceuticals Co.,Ltd
Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and Atorvastatin 40mg in healthy male subjects.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: JINHYUNG KIM
- Email: agpp@ahn-gook.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AG1502
|
|
Active Comparator: Candesartan + Atorvastatin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax (candesartan cilexetil)
Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours
|
0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours
|
AUClast (candesartan cilexetil)
Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours
|
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
|
0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 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
|
0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Anticipated)
February 1, 2016
Study Registration Dates
First Submitted
November 24, 2015
First Submitted That Met QC Criteria
November 24, 2015
First Posted (Estimate)
November 25, 2015
Study Record Updates
Last Update Posted (Estimate)
November 25, 2015
Last Update Submitted That Met QC Criteria
November 24, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Atorvastatin
- Candesartan
Other Study ID Numbers
- AGCA_BE_1501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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