Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: Apetrol ES

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg	Drug: Apetrol ES; sequences of administered drugs
Experimental: Group 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg	Drug: Apetrol ES; sequences of administered drugs
Experimental: Group 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg	Drug: Apetrol ES; sequences of administered drugs
Experimental: Group 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg	Drug: Apetrol ES; sequences of administered drugs
Experimental: Group 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg	Drug: Apetrol ES; sequences of administered drugs
Experimental: Group 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg	Drug: Apetrol ES; sequences of administered drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax, AUClast	Day 34

Secondary Outcome Measures

Outcome Measure	Time Frame
AUCinf, Tmax, t1/2(beta)	Day 34

Collaborators and Investigators

• Sponsor: LG Life Sciences
• Collaborators: Asan Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: April 25, 2011
• First Submitted That Met QC Criteria: April 25, 2011
• First Posted (Estimate): April 26, 2011

Study Record Updates

• Last Update Posted (Estimate): October 10, 2012
• Last Update Submitted That Met QC Criteria: October 8, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: LG-ESCL002