Relative Bioavailability of 2 Oral Formulations of Nintedanib

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nintedanib

• Registration Number: NCT02572752
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-10
• Results First Submitted: 2016-11-08
• Results First Submitted QC: 2016-11-08
• Last Update Submitted: 2016-11-08
• Results First Posted: 2017-01-05
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment T (Test)	Nintedanib	Nintedanib, 1 capsule, oral with 240 mL of water
Treatment R - 1 (Reference)	Nintedanib	Nintedanib, 2 capsules, oral with 240 mL of water
Treatment R - 2 (Reference)	Nintedanib	Nintedanib, 2 capsules, oral with 240 mL of water

Primary Outcome Measures

Name	Time	Method
AUC0-tz	-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference treatment 1 (R1) and Reference treatment 2 (R2) separately.
Cmax	-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.	Maximum measured concentration of the analyte in plasma (Cmax). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.

Secondary Outcome Measures

Name	Time	Method
AUC0-inf	-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany