MedDataX Logo

Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

NCT ID: NCT01764945

Last Updated: 2015-07-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the current study is to investigate the relative bioavailability of two different doses of BI 201335, administered as soft gelatine capsule in comparison to the equivalent doses of three different oral solution per dose of BI 201335.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioavailability of Soft Gelatin Capsule Formulation of BI 201335 NA Compared to the Solution Formulation in Healthy Volunteers

NCT02182284

Healthy
COMPLETED PHASE1

Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male Volunteers

NCT02183363

Healthy
COMPLETED PHASE1

Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects

NCT02183493

Healthy
COMPLETED PHASE1

Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects

NCT02999191

Healthy Volunteers
COMPLETED PHASE1

Safety and Relative Bioavailability of BIBF 1120 Soft Gelatine Capsules Charge 1, BIBF 1120 Soft Gelatine Capsules Charge 2 and BIBF 1120 Drinking Solution in Healthy Male Volunteers

NCT02182193

Healthy
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 BI 201335

low dose

Group Type EXPERIMENTAL

BI 201335 (Reference)

Intervention Type DRUG

soft gelatine capsule, oral administration

BI 201335 (Test)

Intervention Type DRUG

oral solution 3

BI 201335 (Test)

Intervention Type DRUG

oral solution 2

BI 201335 (Test)

Intervention Type DRUG

oral solution 1

2 BI 201335

high dose

Group Type EXPERIMENTAL

BI 201335 (Test)

Intervention Type DRUG

oral solution 3

BI 201335 (Reference)

Intervention Type DRUG

soft gelatine capsule, oral administration

BI 201335 (Test)

Intervention Type DRUG

oral solution 1

BI 201335 (Test)

Intervention Type DRUG

oral solution 2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BI 201335 (Reference)

soft gelatine capsule, oral administration

Intervention Type DRUG

BI 201335 (Test)

oral solution 3

Intervention Type DRUG

BI 201335 (Test)

oral solution 3

Intervention Type DRUG

BI 201335 (Test)

oral solution 2

Intervention Type DRUG

BI 201335 (Reference)

soft gelatine capsule, oral administration

Intervention Type DRUG

BI 201335 (Test)

oral solution 1

Intervention Type DRUG

BI 201335 (Test)

oral solution 1

Intervention Type DRUG

BI 201335 (Test)

oral solution 2

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1\. Healthy male and female subjects

Exclusion Criteria

Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1220.46.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-000687-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1220.46

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers Including the Influence of Food on the Bioavailability of 10 mg BI 1356 BS
NCT02180503 COMPLETED PHASE1
Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers
NCT02161432 COMPLETED PHASE1
Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food
NCT01286571 COMPLETED PHASE1
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
NCT02438696 COMPLETED PHASE1
A Study in Healthy People to Test How 3 Different Formulations of BI 764198 Are Taken up in the Body and How This is Influenced by Food
NCT06955754 COMPLETED PHASE1
Metabolism and Pharmacokinetics of Oral Solution of [14C]-BI 201335 in Healthy Male Volunteers
NCT02182349 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS Administered to Healthy Male Subjects
NCT02173665 COMPLETED PHASE1
Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects
NCT02223000 COMPLETED PHASE1
Safety and Tolerability Study of BIBF 1120 as Intravenous Infusion and Absolute Bioavailability of BIBF 1120 as Soft Gelatine Capsule in Healthy Subjects
NCT02182258 COMPLETED PHASE1
Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of BI 201335 NA and Bioavailability in Healthy Male Subjects
NCT02182323 COMPLETED PHASE1
Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers
NCT02173652 COMPLETED PHASE1
Bioavailability of Four Oral Prototype Extended Release Formulations With BI 11634 in Healthy Male Volunteers
NCT02214953 COMPLETED PHASE1
Pharmacokinetics/Bioavailability of BIBF 1120 Administered to Healthy Male Volunteers
NCT02182076 COMPLETED PHASE1
Bioavailability of BI 44370 TA Drinking Solution or Tablets With and Without a High Fat Meal in Healthy Male and Female Volunteers
NCT02215746 COMPLETED PHASE1
A Study in Healthy People to Compare 2 Different Formulations of BI 1015550 Taken With or Without Food
NCT05428436 COMPLETED PHASE1
Pharmacokinetics and Relative Bioavailability of 11634 Immediate Release Tablet in Healthy Male Volunteers
NCT02214927 COMPLETED PHASE1
To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
NCT01763333 COMPLETED PHASE1
Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of BIBV 308 SE, Versus a Solution of BIBV 308 SE in Healthy Subjects
NCT02223013 COMPLETED PHASE1
A Study in Healthy People to Test How 2 Different Doses of BI 1291583 Are Taken up in the Body When Given in 3 Different Formulations
NCT06631417 COMPLETED PHASE1
Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.
NCT02183662 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 COMPLETED PHASE1
Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food
NCT02229838 COMPLETED PHASE1
A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food
NCT05155306 COMPLETED PHASE1
A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men
NCT03802331 COMPLETED PHASE1
Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects
NCT02182297 COMPLETED PHASE1