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Relative Bioavailability of Telmisartan and Dipyridamole After Co-administration Compared to the Bioavailability of Telmisartan or Dipyridamole Alone in Healthy Female and Male Subjects

10. oktober 2014 oppdatert av: Boehringer Ingelheim

Relative Bioavailability of Telmisartan in Micardis® and of Dipyridamole in Aggrenox® After Co-administration Compared to the Bioavailability of Telmisartan Respectively of Dipyridamole After Oral Administration of 80 mg Telmisartan Respectively of 25 mg ASA/200 mg Extended-release Dipyridamole Alone. An Open-label, Randomised, Single-dose, Four-way Crossover Study in 24 Healthy Female and Male Subjects

To investigate the relative bioavailability of telmisartan respectively of dipyridamole after concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).

To investigate the relative bioavailability of dipyridamole respectively of telmisartan administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2) relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).

Studieoversikt

Status

Fullført

Forhold

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Healthy females and males according to the following criteria:

    Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests

    • No finding deviating from normal and of clinical relevance
    • No evidence of a clinically relevant concomitant disease
  2. Age ≥21 and Age ≤65 years
  3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  2. Surgery of gastrointestinal tract (except appendectomy)
  3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  4. History of relevant orthostatic hypotension, fainting spells or blackouts.
  5. Chronic or relevant acute infections
  6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  7. 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 prior to administration or during the trial
  8. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  10. Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)
  11. Inability to refrain from smoking on trial days
  12. Alcohol abuse (more than 60 g/day)
  13. Drug abuse
  14. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  15. Excessive physical activities (within one week prior to administration or during the trial)
  16. Any laboratory value outside the reference range that is of clinical relevance
  17. Inability to comply with dietary regimen of study centre
  18. History of hereditary fructose intolerance
  19. History of any familial bleeding disorder
  20. Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)
  21. Inability to comply with the investigators instructions

    For female subjects:

  22. Pregnancy
  23. Positive pregnancy test
  24. No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
  25. Inability to maintain this adequate contraception during the whole study period
  26. Lactation period

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: telmisartan and ASA/ER-DP (concomitant)
Aktiv komparator: ASA/ER-DP alone
Eksperimentell: telmisartan and ASA/ER-DP (consecutively)
Aktiv komparator: telmisartan

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
AUC0-∞ (area under the concentration time curve in plasma from 0 extrapolated to infinity)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration
Cmax (maximum concentration in plasma)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall forsøkspersoner med uønskede hendelser
Tidsramme: opptil 8 dager etter siste legemiddeladministrasjon
opptil 8 dager etter siste legemiddeladministrasjon
Antall forsøkspersoner med klinisk signifikante funn i laboratorietester
Tidsramme: opptil 8 dager etter siste legemiddeladministrasjon
opptil 8 dager etter siste legemiddeladministrasjon
AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration
AUCt1-t2 (Area under the concentration time curve in plasma over the time interval t1 to t2)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration
tmax (time from dosing to the maximum concentration of the analytes in plasma)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration
λz (terminal rate constant in plasma)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration
t1/2 (terminal half-life of the analytes in plasma)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration
MRTpo (mean residence time of the analyte in the body after p.o. administration)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Tidsramme: up to 72 hours following drug administration
up to 72 hours following drug administration
Number of subjects with clinically significant findings in vital signs
Tidsramme: up to 8 days after last drug administration
blood pressure, heart rate
up to 8 days after last drug administration
Number of subjects with clinically significant findings in 12 lead ECG
Tidsramme: up to 8 days after last drug administration
up to 8 days after last drug administration
Assessment of tolerability by the investigator on a 4-point scale
Tidsramme: up to 8 days after last drug administration
up to 8 days after last drug administration

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2004

Primær fullføring (Faktiske)

1. juli 2004

Datoer for studieregistrering

Først innsendt

10. oktober 2014

Først innsendt som oppfylte QC-kriteriene

10. oktober 2014

Først lagt ut (Anslag)

13. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. oktober 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. oktober 2014

Sist bekreftet

1. oktober 2014

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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