Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: Apetrol ES

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01342055

LG-ESCL002

Details and patient eligibility

About

A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.

Enrollment: 38 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is a healty male between 20 and 55 years old
• Has BMI result between 19 and 26 kg/m2 at screening
• 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

Exclusion criteria

• Has had a serious illness or medical condition(s) regarding liver, kidney, gastrointestines, pulmonary systems, etc.
• Has had a medical history of gastrointestinal diseases which might affect drug absorption (i.e. Crohn's disease, ulcer) or surgical history.
• Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 6 patient groups

Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg

Experimental group

Treatment:

Drug: Apetrol ES

Group 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg

Experimental group

Treatment:

Drug: Apetrol ES

Group 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg

Experimental group

Treatment:

Drug: Apetrol ES

Group 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg

Experimental group

Treatment:

Drug: Apetrol ES

Group 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg

Experimental group

Treatment:

Drug: Apetrol ES

Group 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg

Experimental group

Treatment:

Drug: Apetrol ES