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OpenTrials
Completed

NCT Number: NCT02259998

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

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

Completed

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Key information

Conditions

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Persantin® new formulation

Drug

Persantin® commercial formulation

Drug

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

    Time frame: up to 8 days after last drug administration

    blood pressure, pulse rate

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open-labelled, Randomised, 2-way Crossover Study to Compare the Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets 75 mg p.o. (Present and Proposed Formulation in France) q.i.d. for Three Days in Healthy Male Volunteers

Important dates

Study start
2001
Primary completion
2001
First posted
Oct 9, 2014
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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