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Effects of Altered Formulation on the Bioequivalence of Tacrolimus in Healthy Female and Male Volunteeers

NCT02341274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-04-07

No results posted yet for this 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.

Conditions

  • Bioequivalence

Interventions

DRUG

Tacrolimus

Bioequivalence study

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Indiana University

    lead OTHER

Principal Investigators

  • Raymond E Galinsky, PharmD · Indiana University

  • Brian Decker, MD, PharmD · Indiana University

  • Lynne S Taylor, PhD · Purdue University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-11
Primary Completion
2018-01-20
Completion
2018-01-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341274 on ClinicalTrials.gov