Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 5/4/2016 |
| Start Date: | February 2009 |
| End Date: | March 2009 |
An Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Sequence, Crossover, Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of TR-701 (Torezolid Phosphate) in Normal Healthy Adults
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium
phosphate salt formulated capsule) after single doses in normal healthy adult subjects and
to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule
formulation compared to di-sodium phosphate salt formulated capsule.
of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium
phosphate salt formulated capsule) after single doses in normal healthy adult subjects and
to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule
formulation compared to di-sodium phosphate salt formulated capsule.
Subjects will receive the following treatments in a crossover design:
Treatment A (Reference): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent
to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room
temperature water;
Treatment B (Test): One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg
TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature
water;
Descriptive statistics will be calculated for PK parameters including Cmax, Tmax, AUC0-t,
and AUC0-inf.
Treatment A (Reference): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent
to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room
temperature water;
Treatment B (Test): One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg
TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature
water;
Descriptive statistics will be calculated for PK parameters including Cmax, Tmax, AUC0-t,
and AUC0-inf.
Inclusion Criteria:
- In good health, determined by no clinically significant findings from medical
history, physical examination, 12-lead ECG, and vital signs;
- Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1
year, surgically sterile for at least 90 days, or agree to use an acceptable form of
contraception
- BMI of 18.5 to 32.0 kg/m2, inclusive
Exclusion Criteria:
- Significant history or clinical manifestation of any significant metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug
compound, food, or other substance
- Pregnancy, lactation, or breastfeeding
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