Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers
NCT ID: NCT01342055
Last Updated: 2012-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2011-03-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg
Apetrol ES
sequences of administered drugs
Group 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg
Apetrol ES
sequences of administered drugs
Group 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg
Apetrol ES
sequences of administered drugs
Group 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg
Apetrol ES
sequences of administered drugs
Group 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg
Apetrol ES
sequences of administered drugs
Group 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg
Apetrol ES
sequences of administered drugs
Interventions
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Apetrol ES
sequences of administered drugs
Eligibility Criteria
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Inclusion Criteria
* Has BMI result between 19 and 26 kg/m2 at screening
* Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Agrees to use an adequate means of contraception during clinical trials
Exclusion Criteria
* Has had a medical history of gastrointestinal diseases which might affect drug absorption (i.e. Crohn's disease, ulcer) or surgical history.
* Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history
20 Years
55 Years
MALE
Yes
Sponsors
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Asan Medical Center
OTHER
LG Life Sciences
INDUSTRY
Responsible Party
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Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Kim YH, Choi HY, Jin S, Noh YH, Kim MJ, Park HJ, Lim HS, Bang K, Lee SH, Bae KS. Tolerability and pharmacokinetics of two formulations of megestrol acetate under fed conditions in healthy volunteers. Clin Ther. 2015 Feb 1;37(2):439-47. doi: 10.1016/j.clinthera.2014.09.022. Epub 2014 Oct 23.
Other Identifiers
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LG-ESCL002
Identifier Type: -
Identifier Source: org_study_id