- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02223000
Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects
21. august 2014 opdateret af: Boehringer Ingelheim
Relative Bioavailability and Tolerability of Various Experimental Formulations of 50 mg BIBV 308 SE Administered Orally Twice a Day Over 3.5 Days to Healthy Subjects (Intraindividual Comparison, Open, Partially Randomised).
Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
9
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Subjects that were previously entered in at least one BIBV 308 SE study to ensure that it is known how these subjects absorb BIBV 308 SE
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >= 18 and <= 55 years
- Broca >= -20% and <= +20 %
Exclusion Criteria:
- Poor individual absorption kinetics of BIBV 308 SE in previous studies
- Any findings of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
- Hypersensitivity to BIBV 308 SE and any of the excipients
- Intake of drugs with a long half-life (> 24 hours) <= 1 month prior to administration or during the trial
- Use of any drugs which might influence the results of the trial <= 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug <= 2 months days prior to administration or during the trial
- Smoker (>= 10 cigarettes or >= 3 cigars or >= 3 pipes/day)
- Inability to refrain from smoking on study days
- Known alcohol or drug abuse
- Blood donation <= 1 month prior to administration
- Excessive physical activities <= 5 days prior to administration
- History of hemorrhagic diathesis
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- Any laboratory value outside the reference range of clinical relevance
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: BIBV 308 SE løsning
|
|
Eksperimentel: BIBV 308 SE capsule 1
|
|
Eksperimentel: BIBV 308 SE capsule 2
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
Tidsramme: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
Tidsramme: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)
Tidsramme: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percent peak-trough fluctuation (%PTF)
Tidsramme: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Tidsramme: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Mean residence time of the analyte in the body (MRTtot)
Tidsramme: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Apparent clearance of the analyte in plasma (CL/f)
Tidsramme: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Ratio of Cmax,ss/AUCss
Tidsramme: up to 84 hours after drug administration
|
up to 84 hours after drug administration
|
Trough concentrations of BIBV 308 SE before doses
Tidsramme: up to day 4
|
up to day 4
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 1998
Primær færdiggørelse (Faktiske)
1. juli 1998
Datoer for studieregistrering
Først indsendt
21. august 2014
Først indsendt, der opfyldte QC-kriterier
21. august 2014
Først opslået (Skøn)
22. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 528.22
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med BIBV 308 SE løsning
-
Boehringer IngelheimAfsluttet