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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: Completed Phase 1 study, sponsored by Indiana University.
NCT02341274 is a Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Ten blood samples (10 mL) will be obtained at zero time (baseline) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours after oral administration of 5 mg capsule of tacrolimus. Each healthy volunteer will be given a single oral dose of tacrolimus, 5 mg, on four separate occasions with at least a 2 week washout between study days. The peak exposure will be assessed by measuring the peak blood concentration (Cmax) obtained directly from the data. The treatment arms (aged Prograf®, fresh generic, aged gen
Interventions
- DRUG Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-11-11 |
| Est. Completion | 2018-01-20 |
| Phase | Phase 1 |
What the finished NCT02341274 record still lists
NCT02341274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Tacrolimus is the first listed.
NCT02341274 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02341274's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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