Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF)Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose)in Healthy Female Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test; Drug: BI 1060469, iFF, Test

• Registration Number: NCT02438696
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective is to investigate the relative bioavailability of two newly developed tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is the comparison of several pharmacokinetic parameters between the treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3 BI 1060469 low dose	BI 1060469, TF2, Test	TF2 followed by iFF followed by TF1
3 BI 1060469 low dose	BI 1060469, iFF, Test	TF2 followed by iFF followed by TF1
3 BI 1060469 low dose	BI 1060469, TF1, Reference	TF2 followed by iFF followed by TF1
1 BI 1060469 high dose	BI 1060469, iFF, Test	TF1 followed by TF2 followed by iFF
1 BI 1060469 high dose	BI 1060469, TF1, Reference	TF1 followed by TF2 followed by iFF
1 BI 1060469 high dose	BI 1060469, TF2, Test	TF1 followed by TF2 followed by iFF
2 BI 1060469 high dose	BI 1060469, iFF, Test	iFF followed by TF1 followed by TF2
2 BI 1060469 high dose	BI 1060469, TF2, Test	iFF followed by TF1 followed by TF2
2 BI 1060469 high dose	BI 1060469, TF1, Reference	iFF followed by TF1 followed by TF2
3 BI 1060469 high dose	BI 1060469, TF2, Test	TF2 followed by iFF followed by TF1
3 BI 1060469 high dose	BI 1060469, iFF, Test	TF2 followed by iFF followed by TF1
3 BI 1060469 high dose	BI 1060469, TF1, Reference	TF2 followed by iFF followed by TF1
1 BI 1060469 low dose	BI 1060469, iFF, Test	TF1 followed by TF2 followed by iFF
1 BI 1060469 low dose	BI 1060469, TF1, Reference	TF1 followed by TF2 followed by iFF
1 BI 1060469 low dose	BI 1060469, TF2, Test	TF1 followed by TF2 followed by iFF
2 BI 1060469 low dose	BI 1060469, iFF, Test	iFF followed by TF1 followed by TF2
2 BI 1060469 low dose	BI 1060469, TF1, Reference	iFF followed by TF1 followed by TF2
2 BI 1060469 low dose	BI 1060469, TF2, Test	iFF followed by TF1 followed by TF2

Primary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	up to 72 h
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)	up to 72 h

Secondary Outcome Measures

Name	Time	Method
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 72 h

Trial Locations

Locations (1)

1333.4.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany