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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Boehringer Ingelheim
- Telefonnummer: 1-800-243-0127
- E-mail: clintriage.rdg@boehringer-ingelheim.com
Studiesteder
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Biberach, Tyskland, 88397
- Rekruttering
- Humanpharmakologisches Zentrum Biberach
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Kontakt:
- Boehringer Ingelheim
- Telefonnummer: 08007234742
- E-mail: deutschland@bitrialsupport.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Reference treatment (R), then Test treatment (T)
Vicadrostat + empagliflozin administered at the same time (R), then Vicadrostat + empagliflozin combined (T) |
Vicadrostat Empagliflozin
Andre navne:
Vicadrostat + empagliflozin combined |
|
Eksperimentel: Test treatment (T), Reference treatment (R)
Vicadrostat + empagliflozin combined (T), then Vicadrostat + empagliflozin administered at the same time (R) |
Vicadrostat Empagliflozin
Andre navne:
Vicadrostat + empagliflozin combined |
Hvad måler undersøgelsen?
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.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1378-0026
- 2025 (U.S. NIH-bevilling/kontrakt)
- U1111-1334-5680 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))
- 2025-524773-16-00 (Registry Identifier: CTIS (EU))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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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