Pharmacokinetics of Midazolam, With and Without Concomita... | NCT02269202

Studies
Pharmacokinetics of Midazolam, With and Without Concomitant Administration of Crobenetine in Healthy Male Subjects

NCT02269202

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Oct 21, 2014Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Midazolam, tablet
Crobenetine, i.v. infusion
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2002

Primary Completion Date

Apr 2002Actual

Completion Date

Not provided

First Submitted Date

Oct 16, 2014

First Submission Date that Met QC Criteria

Oct 20, 2014

First Posted Date

Oct 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2014

Last Update Posted Date

Oct 21, 2014Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
Midazolam and crobenetine	Experimental		Drug: Midazolam, tablet Drug: Crobenetine, i.v. infusion
Midazolam and placebo	Placebo Comparator		Drug: Midazolam, tablet Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Midazolam, tablet	Drug		Midazolam and crobenetine Midazolam and placebo
Crobenetine, i.v. infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve of midazolam from zero time extrapolated to infinity (AUC0-infinity)		up to 24 hours after start of drug administration
Maximum observed concentration of midazolam in plasma (Cmax)		up to 24 hours after start of drug administration

Secondary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve (AUC)		up to 24 hours after start of drug administration
Time to maximum observed concentration (tmax)		up to 24 hours after start of drug administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All participants in the study should be healthy males, range from 21 to 50 years of age and their bodymass index (BMI) be within 18.5 to 29.9 kg/m2

Exclusion Criteria:

Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy), which is deemed relevant to the trial as judged by the investigator
Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study (except substitution therapy regarding thyroid gland)
Use of any drugs that might influence the results of the trial (within one week prior to administration or during the trial)
Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (> 60 g/day)
Drug abuse
Blood donation (≥ 100 mL, within four weeks prior to administration or during the trial)
Excessive physical activities (within the last week before the study)
Any laboratory value outside the reference range of clinical relevance

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008874	Midazolam
C408069	BIII 890 CL

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring