Pharmacokinetics of Two Different Persantin® Sugar Coated... | NCT02259998

Studies
Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers

NCT02259998

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Oct 9, 2014Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Persantin® new formulation
Persantin® commercial formulation

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

Oct 2001

Primary Completion Date

Dec 2001Actual

Completion Date

Not provided

First Submitted Date

Oct 7, 2014

First Submission Date that Met QC Criteria

Oct 7, 2014

First Posted Date

Oct 9, 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 7, 2014

Last Update Posted Date

Oct 9, 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

30Actual

Label	Type	Description	Intervention Names
Persantin® new formulation	Experimental		Drug: Persantin® new formulation
Persantin® commercial formulation	Active Comparator		Drug: Persantin® commercial formulation

Name	Type	Description	Arm Group Labels	Other Names
Persantin® new formulation	Drug		Persantin® new formulation
Persantin® commercial formulation

Measure	Description	Time Frame
Area under the concentration time curve from 48 to 58 hours (AUC48-58)		48 - 58 hours
Maximum concentration from 48 to 58 hours (Cmax48-58)		48 - 58 hours

Measure	Description	Time Frame
Peak trough fluctuation (% PTF)		up to 48 hours
Minimum concentration from 48 to 58 hours (Cmin48-58)		48 - 58 hours
Cmax48-58/AUC48-58 ratio

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 body mass index (BMI) be within 18.5 to 29.9 kg/m2
All participants must give their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study

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 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 10 half-lives of the respective drug before enrolment in the study or during the study
Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
Participation in another trial with an investigational drug (<= 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)
Any laboratory value outside the clinically accepted reference range
Excessive physical activities within the last week before the trial or during the trial

Following exclusion criteria are of special interest for this study:

History of haemorrhagic diathesis
History of gastro-intestinal ulcer, perforation or bleeding
Glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency

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