Pharmacokinetics and Safety Study of Apetrol ES

NCT02446353 | Completed Phase 1

• 1 other identifier: LG-ESCL001
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Male Volunteers

Outcome Measures

Primary Outcomes (2)

• Cmax

  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

  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 Outcomes (3)

• AUCinf, %AUCextra

  Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h

• Tmax

  Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h

• t1/2

  Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h

Study Arms (4)

Megace : fed

EXPERIMENTAL

Megace / Apetrol ES : comparator / test, fed

Drug: Apetrol ES / Megace

Apetrol ES : fed

EXPERIMENTAL

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

Drug: Apetrol ES / Megace

Megace : fasting

EXPERIMENTAL

Megace / Apetrol ES : comparator / test, fasting

Drug: Apetrol ES / Megace

Apetrol ES : fasting

EXPERIMENTAL

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

Drug: Apetrol ES / Megace

Interventions

Apetrol ES / Megace DRUG

Sequences of administered drugs

Also known as: Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL

Apetrol ES : fasting; Apetrol ES : fed; Megace : fasting; Megace : fed

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Life Sciences: lead
• Severance Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 27191767 DERIVED

MeSH Terms

Interventions

Megestrol Acetate

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kyungsoo Park, Ph D, MD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 18, 2015
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 18, 2015

Record last verified: 2015-05