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CompletedNCT02259998Updated Oct 9, 2014

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

A Phase 1 interventional study of Persantin® new formulation and Persantin® commercial formulation in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-09.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Male
01

Study summary

To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,300 studies on the registry; 59 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Persantin® new formulation

    Drug: Persantin® new formulation

  • Active comparator
    Persantin® commercial formulation

    Drug: Persantin® commercial formulation

Interventions

  • DrugPersantin® new formulation
  • DrugPersantin® commercial formulation
06

What researchers measure

Primary outcomes

  1. Area under the concentration time curve from 48 to 58 hours (AUC48-58)

    Time frame: 48 - 58 hours

  2. Maximum concentration from 48 to 58 hours (Cmax48-58)

    Time frame: 48 - 58 hours

Secondary outcomes

  1. Peak trough fluctuation (% PTF)

    Time frame: up to 48 hours

  2. Minimum concentration from 48 to 58 hours (Cmin48-58)

    Time frame: 48 - 58 hours

  3. Cmax48-58/AUC48-58 ratio

    Time frame: 48 - 58 hours

  4. Time to maximum concentration from 48 to 58 hours (Tmax48-58)

    Time frame: up to 58 hours

  5. Amount excreted in urine (Ae)

    Time frame: up to 24 hours after drug administration

  6. Number of participants with adverse events

    Time frame: up to 8 days after last drug administration

  7. Number of participants with clinically significant findings in vital functions

    blood pressure, pulse rate

    Time frame: up to 8 days after last drug administration

  8. Number of participants with clinically significant findings in ECG

    Time frame: up to 8 days after last drug administration

  9. Number of participants with clinically significant findings in laboratory tests

    Time frame: up to 8 days after last drug administration

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2001 and a primary completion of Dec 2001. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2014
First posted
Oct 9, 2014
Start
Oct 2001
Primary completionActual
Dec 2001
Last update
Oct 9, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02259998
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 9, 2014
Start date
Oct 2001
Primary completion
Dec 2001
Last update
Oct 9, 2014
View the source record on ClinicalTrials.gov ↗

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