Healthy
Conditions
Keywords
Male Volunteers
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
Interventions
DRUGApetrol ES / Megace
Sequences of administered drugs
Sponsors
Severance Hospital
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 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) |
| AUClast | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf, %AUCextra | 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) |
| Tmax | 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) |
| t1/2 | 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) |
Outcome results
None listed