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

NCT02259998 | Completed Phase 1

• 1 other identifier: 21.449
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• 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

  48 - 58 hours

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

  up to 58 hours

• Amount excreted in urine (Ae)

  up to 24 hours after drug administration

Study Arms (2)

Persantin® new formulation

EXPERIMENTAL

Drug: Persantin® new formulation

Persantin® commercial formulation

ACTIVE COMPARATOR

Drug: Persantin® commercial formulation

Interventions

Persantin® new formulation DRUG

Persantin® new formulation

Persantin® commercial formulation DRUG

Persantin® commercial formulation

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2001
• Primary Completion: December 1, 2001
• Last Updated: October 9, 2014

Record last verified: 2014-10