Skip to main content
OpenTrials
Completed

NCT Number: NCT01342055

Pharmacokinetics and Safety Study of Apetrol ES 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Male Volunteers

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apetrol ES

Drug

sequences of administered drugs

Primary outcomes

  1. Cmax, AUClast

    Time frame: Day 34

Secondary outcomes

  1. AUCinf, Tmax, t1/2(beta)

    Time frame: Day 34

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Collaborators

  • Asan Medical Center

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 26, 2011
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.