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Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01342055
Recruitment Status : Completed
First Posted : April 26, 2011
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
LG Life Sciences

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.

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: Apetrol ES Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

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



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

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


Information from the National Library of Medicine

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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

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

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 Posted: April 26, 2011    Key Record Dates
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