Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact
The purpose of the study is to compare the relative bioavailability and pharmacokinetics of tolvaptan 15 mg tablets administered orally versus tolvaptan via nasogastric (NG) tube in healthy male and female subjects.
This study is an open 2-treatment, 2-period, 2-sequence crossover study to compare the relative bioavailability of tolvaptan tablets to tolvaptan given via nasogastric tube in 28 healthy adults. Subjects will be randomized to one of the two treatment sequences; either tolvaptan oral tablets swallowed intact followed by a tablet crushed and administered via nasogastric tube, or the reverse sequence. Serial pharmacokinetic samples will be collected following each tolvaptan administration and safety assessments will be performed. The relative bioavailability of tolvaptan administered via nasogastric tube will be compared to tolvaptan tablets swallowed intact.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of the Relative Oral Bioavailability of Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact|
- Area under the plasma drug concentration-time curve from time 0 to infinity (AUC) [ Time Frame: PK samples: from pre-dose to 36 hours ]
- Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t)) [ Time Frame: PK samples: from pre-dose to 36 hours ]
- Maximum plasma concentration (Cmax) [ Time Frame: PK samples: from pre-dose to 36 hours ]
- Time to maximal concentration (Tmax) [ Time Frame: PK samples: pre-dose to 36 hours ]
|Study Start Date:||January 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Experimental: Tolvaptan Intact Tablet Orally||
Tolvaptan 15 mg administered once orally as an intact tablet.
Other Name: Samsca
|Experimental: Tolvaptan via Nasogastric Tube||
Tolvaptan 15 mg administered once via nasogastric tube.
Other Name: Samsca
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261481
|United States, North Carolina|
|University of North Carolina Healthcare|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||J. Herbert Patterson, PharmD||University of North Caronlina - Eshelman School of Pharmacy|
|Study Director:||Elizabeth B McNeely, PharmD||University of North Caronlina - Eshelman School of Pharmacy|