Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342055
• Other study ID #: LG-ESCL002
• Status: Completed
• Phase: Phase 1
• First received: April 25, 2011
• Last updated: October 8, 2012
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2012
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• Apetrol ES
sequences of administered drugs

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
LG Life Sciences	Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax, AUClast		Day 34	No
Secondary	AUCinf, Tmax, t1/2(beta)		Day 34	No