Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fasting and Fed Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gyu-Jeong Noh, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01456624
First received: October 19, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fasting and fed condition.


Condition Intervention Phase
Healthy
Drug: Megace
Drug: DW-ES(B)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fasting and Fed Conditions in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Safety (normal results for safety tests) [ Time Frame: 30days ] [ Designated as safety issue: Yes ]
    Adverse events Physical examination, vital signs


Enrollment: 56
Study Start Date: September 2011
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Megace / Fasting condition
800mg
Drug: Megace
800mg
Experimental: DW-ES(B) / Fasting condition
625mg
Drug: DW-ES(B)
625mg
Active Comparator: Megace / Fed condition
800mg
Drug: Megace
800mg
Experimental: DW-ES(B) / Fed condition
625mg
Drug: DW-ES(B)
625mg

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult males aged 20 to 40 years at screening.
  • No significant congenital/chronic disease. No symptoms in physical examination.
  • Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
  • Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

  • History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
  • History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456624

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

Additional Information:
No publications provided

Responsible Party: Gyu-Jeong Noh, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01456624     History of Changes
Other Study ID Numbers: 2011-0686
Study First Received: October 19, 2011
Last Updated: June 23, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Megestrol
Megestrol Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014