Pharmacokinetics and Safety Study of Apetrol ES (Apetrol)

May 13, 2015 updated by: LG Life Sciences

A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® Under Fasting and Fed Conditions in Healthy Male Volunteers

A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® in Healthy Male Volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

[Part 1] fasting [Part 2] fed

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Is a healty male between 20 and 55 years old.
  • In a ± 20% than ideal body weight. [ideal body weight(kg) = height(cm)-100) x 0.9 (Broca's rule)
  • Subjects who are considered to be suitable in conducting the clinical trial in serum test, hematology test, hemato-chemical test, urine test and 12-ECG result.
  • 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
  • Subject who has voluntarily decided to participate in this clinical trial and consented in writing.

Exclusion Criteria:

  • Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history.
  • Subjects who have present condition or past history of any disease involving liver, kidney, nervous system, immune system, respiratory system, or endocrine system; hematologic and oncologic disease; cardiovascular disease; or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc. that may affect ADME of investigational medicinal products.
  • In the vital signs measured in sitting position at the screening visit, subjects who have hypertension desease(a systolic blood pressure of ≥ 150 mmHg or a diastolic blood pressure of ≥ 100 mmHg).
  • Diabetic patients or the patients who are abnormal of impaired glucose tolerance.
  • The patients who have a history of Arterial Embolism.
  • The patients who have a history of adrenal insufficiency like hypotension or nausea or vertigo or asthenia or etc.
  • Subjects who have a history of drug abuse or shown positive reaction to drugs that may be abused from a urine drug screening
  • Subjects who took any specialized drug or an herbal medication within 2 weeks before the date of first administration or took any over the counter (OTC) drug within 1 week (however, they may be included as subjects if appropriate depending on the investigator's discretion)
  • Subjects who had whole blood donation within 2 months or component blood donation within 1 month before the clinical trial.
  • Subjects who have abnormal diets that may affect ADME of investigational medicinal products.
  • Subjects who have been drinking extremely alcohol and caffeine (more than caffeine 5 cups/day, soju 3 cups/day, beer 3 cups/day, liquors 2 cups/day, 10 cigarettes/day) or can't refrain from drinking during the clinical trial period.
  • Subjects who had administration a barbiturates within 1 month before the date of first drug administration
  • Subjects who already participated in other clinical trials within 2 months before this clinical trial.
  • Subjects who are considered to be unsuitable in conducting the clinical trial for other reason at the principal investigator's discretionary judgment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Megace : fed
Megace / Apetrol ES : comparator / test, fed
Drug: Apetrol ES / Megace
Sequences of administered drugs
Other Names:
  • Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL
Experimental: Apetrol ES : fed
Apetrol ES / Megace : test / comparator, fed, cross-over
Drug: Apetrol ES / Megace
Sequences of administered drugs
Other Names:
  • Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL
Experimental: Megace : fasting
Megace / Apetrol ES : comparator / test, fasting
Drug: Apetrol ES / Megace
Sequences of administered drugs
Other Names:
  • Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL
Experimental: Apetrol ES : fasting
Apetrol ES / Megace : test / comparator, fasting, cross-over
Drug: Apetrol ES / Megace
Sequences of administered drugs
Other Names:
  • Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
16 times(fasting), 15 times(fed)
Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
AUClast
Time Frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
16 times(fasting), 15 times(fed)
Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUCinf, %AUCextra
Time Frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
16 times(fasting), 15 times(fed)
Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
Tmax
Time Frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
16 times(fasting), 15 times(fed)
Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
t1/2
Time Frame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
16 times(fasting), 15 times(fed)
Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LG Life Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Severance Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kyungsoo Park, Ph D, MD, Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LG-ESCL001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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