Pharmacokinetics and Safety Study of Apetrol ES

Study Overview
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Brief Summary
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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
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[Part 1] fasting [Part 2] fed

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Apetrol ES / Megace


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Megace : fed<br>Megace / Apetrol ES : comparator / test, fed | Drug: Apetrol ES / Megace<br>* Sequences of administered drugs<br>* Other names: Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL;|
| Experimental: Apetrol ES : fed<br>Apetrol ES / Megace : test / comparator, fed, cross-over | Drug: Apetrol ES / Megace<br>* Sequences of administered drugs<br>* Other names: Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL;|
| Experimental: Megace : fasting<br>Megace / Apetrol ES : comparator / test, fasting | Drug: Apetrol ES / Megace<br>* Sequences of administered drugs<br>* Other names: Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL;|
| Experimental: Apetrol ES : fasting<br>Apetrol ES / Megace : test / comparator, fasting, cross-over | Drug: Apetrol ES / Megace<br>* Sequences of administered drugs<br>* Other names: Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf, %AUCextra | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Volunteers