NCT01084499

Bioequivalence Study of Letrozole 2.5 mg Tablets

Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence

Detailed description

The purpose of this study was to determine the bioequivalence of letrozole 2.5 mg tablets after administration of single doses to normal healthy Korean subjects under fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Femara (Sequence 1)	Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.
DRUG	Peratra (Sequence 1)	Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.
DRUG	Femara (Sequence 2)	Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.
DRUG	Peratra (Sequence 2)	Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2010-03-10
• Last updated: 2019-03-29
• Results posted: 2019-03-29