Pharmacokinetics and Safety Study of Apetrol ES

NCT ID: NCT02446353

Last Updated: 2015-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-10-31

Brief Summary

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.

Detailed Description

[Part 1] fasting [Part 2] fed

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Megace : fed

Megace / Apetrol ES : comparator / test, fed

Group Type: EXPERIMENTAL

Apetrol ES / Megace

Intervention Type: DRUG

Sequences of administered drugs

Apetrol ES : fed

Apetrol ES / Megace : test / comparator, fed, cross-over

Group Type: EXPERIMENTAL

Apetrol ES / Megace

Intervention Type: DRUG

Sequences of administered drugs

Megace : fasting

Megace / Apetrol ES : comparator / test, fasting

Group Type: EXPERIMENTAL

Apetrol ES / Megace

Intervention Type: DRUG

Sequences of administered drugs

Apetrol ES : fasting

Apetrol ES / Megace : test / comparator, fasting, cross-over

Group Type: EXPERIMENTAL

Apetrol ES / Megace

Intervention Type: DRUG

Sequences of administered drugs

Interventions

Apetrol ES / Megace

Sequences of administered drugs

Intervention Type: DRUG

Other Intervention Names

Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyungsoo Park, Ph D, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

References

Chae DW, Son H, Guk J, Park C, Park K. Pharmacokinetics of a nanocrystal-containing megestrol acetate formulation: a single-dose, randomized, open-label, 2-part, 2-period crossover study in healthy Korean subjects. Int J Clin Pharmacol Ther. 2016 Sep;54(9):698-704. doi: 10.5414/CP202574.

Reference Type: DERIVED

PMID: 27191767 (View on PubMed)

Other Identifiers

LG-ESCL001

Identifier Type: -

Identifier Source: org_study_id