Phase 4
Completed N=28
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
Source: ClinicalTrials.gov NCT00952653 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR — 54.69; 39.45 ng*hr/mL
Summary
The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount of drug in the body and the effect of the drug will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR |
54.69; 39.45 | — |
| PRIMARY Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR |
21.20; 18.24 | — |
| PRIMARY 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR |
36.87; 30.74 | — |
| PRIMARY 1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR |
14.93; 15.10 | — |
| SECONDARY Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR |
52.85; 38.11 | — |
| SECONDARY Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR |
0.517; 0.500 | — |
| SECONDARY Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR |
5.320; 4.648 | — |
| SECONDARY 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR |
37.09; 32.42 | — |
| SECONDARY 1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR |
1.00; 0.500 | — |
| SECONDARY 1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR |
5.396; 4.616 | — |
Eligibility Criteria
Inclusion Criteria
- Men or non-pregnant, non-lactating women, 18 to 55 years of age inclusive at screening.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 Ilbs).
Exclusion Criteria
- Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Presence or history of glaucoma or intraocular pressure.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
- Allergy to midazolam, other benzodiazepine, desvenlafaxine, or venlafaxine.
- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) with 7 days before study day 1.
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements. History of drug abuse within 1 year before study day 1.
Data sourced from ClinicalTrials.gov (NCT00952653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.