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NCT02341274 · ClinicalTrials.gov registry record · Phase 1
Effects of Altered Formulation on the Bioequivalence of Tacrolimus in Healthy Female and Male Volunteeers
A Phase 1 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02341274 is a Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 24 participants.
The verdict
NCT02341274, a Phase 1 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Amorphous solid dispersion (ASD) formulations are increasingly used by the pharmaceutical industry to develop poorly water-soluble drugs into effective oral dosage forms. Examples include the antifungal drug itraconazole, the HIV protease inhibitor combination, lopinavir/ritonavir and the immunosuppressive, tacrolimus. There is potential for significant variation in bioavailability of ASD and thus heightened concern regarding the therapeutic efficacy as generic versions of these poorly water-soluble compounds become approved. The variation in bioavailability is to be expected because of our limited understanding of the precise physical chemistry of drug polymer amorphous solid dispersion formulations.
Interventions
- DRUG Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-11-11 |
| Est. Completion | 2018-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02341274
The ClinicalTrials.gov registry entry for NCT02341274 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tacrolimus is the first listed.
NCT02341274 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02341274 about?
NCT02341274 is a clinical study titled "Effects of Altered Formulation on the Bioequivalence of Tacrolimus in Healthy Female and Male Volunteeers". Amorphous solid dispersion (ASD) formulations are increasingly used by the pharmaceutical industry to develop poorly water-soluble drugs into effective oral dosage forms. Examples include the antifungal drug itraconazole, the HIV protease inhibitor combination, lopinavir/ritonavir and the immunosupp...
What is the current status of trial NCT02341274?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-11-11. Estimated completion is 2018-01-20.
What interventions are being tested in trial NCT02341274?
The interventions under investigation include: Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT02341274?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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