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Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

This study has been completed.
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01342055
First received: April 25, 2011
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Cmax, AUClast [ Time Frame: Day 34 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUCinf, Tmax, t1/2(beta) [ Time Frame: Day 34 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342055

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

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01342055     History of Changes
Other Study ID Numbers: LG-ESCL002
Study First Received: April 25, 2011
Last Updated: October 8, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013