Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

This study has been completed.

Sponsor:

Collaborator:

Asan Medical Center

Information provided by (Responsible Party):

LG Life Sciences

ClinicalTrials.gov Identifier:

NCT01342055

First received: April 25, 2011

Last updated: October 8, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 25, 2011
Last Updated Date	October 8, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 25, 2011)	Cmax, AUClast [ Time Frame: Day 34 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01342055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 25, 2011)	AUCinf, Tmax, t1/2(beta) [ Time Frame: Day 34 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers
Official Title ^ICMJE	Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy Male Volunteers
Intervention ^ICMJE	Drug: Apetrol ES sequences of administered drugs
Study Arm (s)	Experimental: Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg Intervention: Drug: Apetrol ES Experimental: Group 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg Intervention: Drug: Apetrol ES Experimental: Group 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg Intervention: Drug: Apetrol ES Experimental: Group 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg Intervention: Drug: Apetrol ES Experimental: Group 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg Intervention: Drug: Apetrol ES Experimental: Group 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg Intervention: Drug: Apetrol ES
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	Completed
Enrollment ^ICMJE	38
Completion Date	August 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Gender	Male
Ages	20 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01342055
Other Study ID Numbers ^ICMJE	LG-ESCL002
Has Data Monitoring Committee	No
Responsible Party	LG Life Sciences
Study Sponsor ^ICMJE	LG Life Sciences
Collaborators ^ICMJE	Asan Medical Center
Investigators ^ICMJE	Not Provided
Information Provided By	LG Life Sciences
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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