Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01190514
First received: August 24, 2010
Last updated: December 21, 2011
Last verified: December 2011
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Purpose
To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.
To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression - Major Depressive Disorder |
Drug: desvenlafaxine succinate sustained release |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1, Open-Label, Randomized, Single-Dose, 4-Treatment, 4-Period Crossover Bioequivalence Study Comparing 25 Mg and 50 Mg Formulations of DVS-233 SR and Investigate Food Effect on 50 Mg Formulations of DVS-233 SR Tablet Under Fed and Fasted Conditions |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48) [ Time Frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose ] [ Designated as safety issue: No ]Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).
- Maximum Plasma Concentration (Cmax) [ Time Frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose ] [ Designated as safety issue: No ]Cmax measured as nanograms divided by milliliters (ng/mL).
Secondary Outcome Measures:
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose ] [ Designated as safety issue: No ]
- Terminal Elimination Half-life (t 1/2) [ Time Frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose ] [ Designated as safety issue: No ]Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.
- Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) [ Time Frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose ] [ Designated as safety issue: No ]Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
- Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast) [ Time Frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| Study Start Date: | September 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bioequivalence and Food effect |
Drug: desvenlafaxine succinate sustained release
Two tablets of 25 mg, single administration, under fed condition
Other Name: DVS-233 SR, Pristiq
Drug: desvenlafaxine succinate sustained release
One tablet of 50 mg, single administration, under fed condition
Other Name: DVS-233 SR, Pristiq
Drug: desvenlafaxine succinate sustained release
Two tablets of 25 mg, single administration, under fast condition
Other Name: DVS-233 SR, Pristiq
Drug: desvenlafaxine succinate sustained release
One tablet of 50 mg, single administration, under fast condition
Other Name: DVS-233 SR, Pristiq
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female subjects.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01190514 History of Changes |
| Other Study ID Numbers: | B2061035 |
| Study First Received: | August 24, 2010 |
| Results First Received: | December 21, 2011 |
| Last Updated: | December 21, 2011 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Keywords provided by Pfizer:
|
DVS SR healthy Bioequivalence study |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders O-desmethylvenlafaxine Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013