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Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342055
First Posted: April 26, 2011
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
LG Life Sciences
  Purpose
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.

Condition Intervention Phase
Healthy Male Volunteers Drug: Apetrol ES Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Cmax, AUClast [ Time Frame: Day 34 ]

Secondary Outcome Measures:
  • AUCinf, Tmax, t1/2(beta) [ Time Frame: Day 34 ]

Enrollment: 38
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342055


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Asan Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01342055     History of Changes
Other Study ID Numbers: LG-ESCL002
First Submitted: April 25, 2011
First Posted: April 26, 2011
Last Update Posted: October 10, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Megestrol Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Physiological Effects of Drugs