Phase 1: testing Vicadrostat for Healthy
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.
Official registry: https://clinicaltrials.gov/study/NCT07845630 · Boehringer Ingelheim · enrollment listed as 36
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Vicadrostat, Empagliflozin, or Vicadrostat + empagliflozin. The registry lists allocation as randomized. 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.
They plan to enroll about 36 people at Biberach. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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)
Interventions: Vicadrostat, Empagliflozin, Vicadrostat + empagliflozin
Primary outcome (registry wording): 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)
Who it is for (from inclusion criteria)
- Ages 18 Years to 55 Years
- 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)
- Further who can join apply
Who the registry excludes
- 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
Public study contact (from the registry)
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Humanpharmakologisches Zentrum Biberach — Biberach, Germany (recruiting)
FAQ about this NCT record
Is NCT07845630 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07845630?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07845630?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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