A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Bioequivalence of Two Different Vicadrostat / Empagliflozin Formulations Following Oral Administration in Healthy Trial Participants (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)
The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Boehringer Ingelheim
- Telefonnummer: 1-800-243-0127
- E-post: clintriage.rdg@boehringer-ingelheim.com
Studiesteder
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Biberach, Tyskland, 88397
- Rekruttering
- Humanpharmakologisches Zentrum Biberach
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Ta kontakt med:
- Boehringer Ingelheim
- Telefonnummer: 08007234742
- E-post: deutschland@bitrialsupport.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electrocardiogram, and clinical laboratory tests
- Age of 18 to 55 years (inclusive)
- Body mass index of 18.5 to 29.9 kg / m^2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice and local legislation prior to admission to the trial
- Further inclusion criteria apply.
Exclusion Criteria:
- Any finding in the medical examination (including Blood pressure, Pulse rate or Electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Further exclusion criteria apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Reference treatment (R), then Test treatment (T)
Vicadrostat + empagliflozin administered at the same time (R), then Vicadrostat + empagliflozin combined (T) |
Vicadrostat Empagliflozin
Andre navn:
Vicadrostat + empagliflozin combined |
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Eksperimentell: Test treatment (T), Reference treatment (R)
Vicadrostat + empagliflozin combined (T), then Vicadrostat + empagliflozin administered at the same time (R) |
Vicadrostat Empagliflozin
Andre navn:
Vicadrostat + empagliflozin combined |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Tidsramme: Up to 4 days.
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Up to 4 days.
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Maximum measured concentration of the analyte in plasma (Cmax)
Tidsramme: Up to 4 days.
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Up to 4 days.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Tidsramme: Up to 4 days.
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Up to 4 days.
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1378-0026
- 2025 (U.S. NIH-stipend/kontrakt)
- U1111-1334-5680 (Registeridentifikator: WHO International Clinical Trials Registry Platform (ICTRP))
- 2025-524773-16-00 (Registeridentifikator: CTIS (EU))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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