Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01342055

Enrollment

Registered

2011-04-26

Start date

2011-03-31

Completion date

2011-08-31

Last updated

2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy 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® under Fed Conditions in Healthy Male Volunteers.

Interventions

DRUGApetrol ES

sequences of administered drugs

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 * 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

Design outcomes

Primary

Measure	Time frame
Cmax, AUClast	Day 34

Secondary

Measure	Time frame
AUCinf, Tmax, t1/2(beta)	Day 34

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026