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

• Status: Completed
• Trial end date: 2018-01-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University
• Collaborator: Food and Drug Administration (FDA)
• Treatments: Methamphetamine; Tacrolimus

Criteria

Inclusion Criteria:

• Male and female subjects between 18 and 49 years old.

• Healthy individuals without any significant medical condition.

• Nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at lest one month prior to and until the completion of the study. The entire study for each volunteer will last for minimum of 42 days.

• Ability to commit the time requested for this study.

• Ability to swallow capsules.

Exclusion Criteria:

• Underweight (weigh less than 52 kg or 114 lb.) or overweight (body mass index (BMI) greater than 32).

• History or current alcohol or drug abuse (more than 3 alcoholic drinks per day on a regular basis).

• History or current significant health conditions such as heart, liver, or kidney.

• History or current psychiatric illness such as depression, anxiety, or nervousness.

• History or current gastrointestinal disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs.

• Individuals having a serious infection within the last month.

• Donation of blood within the past two months.

• Blood hemoglobin less than 12.5 mg/dL.

• Individuals who are regularly taking prescriptions, over-the-counter, herbal or dietary supplements, alternative medications, or hormonal agents (i.e. oral contraceptives, intra-uterine device with hormones).

• Females with a positive pregnancy test.

• Breastfeeding.

• Females of child-bearing potential who are unable or unwilling to either practice abstinence or to use two non-hormonal forms of birth control (e.g. condom, contraceptive foam) up until the study completion, which will take a total of 30 days. Participation in a research study or use of an investigational drug in the last two months.

• An employee or student under supervision of any of the investigators of this study.

• Individuals who cannot state a good understanding of this study including risks and requirements; are unable to follow the rules of this study.