Pharmacokinetics and Safety Study of Apetrol ES

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Apetrol ES / Megace

• Registration Number: NCT02446353
• Lead Sponsor: LG Life Sciences

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

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-06
• Study Completion: 2010-10
• Status Verified: 2015-05
• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-13
• Last Update Submitted: 2015-05-13
• Study First Posted: 2015-05-18
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Megace : fed	Apetrol ES / Megace	Megace / Apetrol ES : comparator / test, fed
Apetrol ES : fed	Apetrol ES / Megace	Apetrol ES / Megace : test / comparator, fed, cross-over
Megace : fasting	Apetrol ES / Megace	Megace / Apetrol ES : comparator / test, fasting
Apetrol ES : fasting	Apetrol ES / Megace	Apetrol ES / Megace : test / comparator, fasting, cross-over

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)