Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers
Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers
1 other identifier
interventional
38
1 country
1
Brief Summary
A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 25, 2011
CompletedFirst Posted
Study publicly available on registry
April 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedOctober 10, 2012
October 1, 2012
2 months
April 25, 2011
October 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Cmax, AUClast
Day 34
Secondary Outcomes (1)
AUCinf, Tmax, t1/2(beta)
Day 34
Study Arms (6)
Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg
EXPERIMENTALGroup 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg
EXPERIMENTALGroup 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg
EXPERIMENTALGroup 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg
EXPERIMENTALGroup 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg
EXPERIMENTALGroup 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg
EXPERIMENTALInterventions
sequences of administered drugs
Eligibility Criteria
You may qualify if:
- Is a healty male between 20 and 55 years old
- 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
You may not qualify if:
- Has had a serious illness or medical condition(s) regarding liver, kidney, gastrointestines, pulmonary systems, etc.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
- Asan Medical Centercollaborator
Study Sites (1)
Asan Medical Center
Seoul, South Korea
Related Publications (1)
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.
PMID: 25450470DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2011
First Posted
April 26, 2011
Study Start
March 1, 2011
Primary Completion
May 1, 2011
Study Completion
August 1, 2011
Last Updated
October 10, 2012
Record last verified: 2012-10