A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 19 - 55 |
| Updated: | 10/13/2017 |
| Start Date: | August 31, 2017 |
| End Date: | October 7, 2017 |
A Phase 1, Open Label, Randomized, 2-Period, 2-Treatment, Crossover Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects
This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover
study to evaluate the drug-drug interaction potential between plazomicin and metformin in
healthy subjects.
study to evaluate the drug-drug interaction potential between plazomicin and metformin in
healthy subjects.
Key Inclusion Criteria:
- Medically healthy, with no clinically significant medical history, physical
examination findings, vital signs, or ECG findings
Key Exclusion Criteria:
- Estimated creatinine clearance <90 mL/min
- Use of tobacco- or nicotine-containing products
- History in the past 90 days of prior trauma to the outer or internal structures of the
ear or tinnitus
- History or family history of vestibular disorder, chronic vertigo (sensation of
spinning), chronic dizziness
- History of hearing loss or a family history of hearing loss, or a prior diagnosis of
sensorineural hearing loss or Ménière's disease
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