Clinical trial NCT02446353: Pharmacokinetics and Safety Study of Apetrol ES
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Male Volunteers
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
First posted: 2015-05-18
Enrollment: 79
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Cmax
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
measure: AUClast
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
Secondary outcomes:
measure: AUCinf, %AUCextra
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
measure: Tmax
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
measure: t1/2
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
Other outcomes:
Locations:
Study officials:
affiliation: Yonsei University
name: Kyungsoo Park, Ph D, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.