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Trial record 38 of 405 for:    ARIPIPRAZOLE

Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01188668
Recruitment Status : Completed
First Posted : August 25, 2010
Results First Posted : October 17, 2011
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Pharmacokinetics
Cytochrome P-450 CYP2D6
CYP3A4 Protein, Human
Interventions Drug: Aripiprazole
Drug: Aripiprazole + desvenlafaxine succinate sustained release
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg
Hide Arm/Group Description Aripiprazole (ARIP) as a single oral dose of 5 milligrams (mg) Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Period Title: Period 1: ARIP Alone
Started 38
Completed 36
Not Completed 2
Reason Not Completed
Protocol Violation             2
Period Title: Period 2: Coadministration ARIP + DVS SR
Started 36
Completed 33
Not Completed 3
Reason Not Completed
Lost to Follow-up             2
Withdrawal by Subject             1
Arm/Group Title Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg
Hide Arm/Group Description Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1. DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
35.2  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
18
  47.4%
Male
20
  52.6%
1.Primary Outcome
Title Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description 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 - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population: all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=Number of participants contributing to the mean.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 37 35
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
1494  (699.98) 1604  (561.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole 5 mg (Period 1), Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 105.97
Confidence Interval (2-Sided) 90%
101.39 to 110.76
Estimation Comments Values have been back-transformed from the log scale.
2.Secondary Outcome
Title Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description Cmax measured as nanograms per milliliters (ng/mL).
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=Number of participants contributing to the mean.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 38 35
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
24.66  (7.6031) 24.69  (7.4186)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole 5 mg (Period 1), Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 101.05
Confidence Interval (2-Sided) 90%
92.94 to 109.87
Estimation Comments Values have been back-transformed from the log scale.
3.Secondary Outcome
Title Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description Time for maximum observed plasma concentration.
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=Number of participants contributing to the median.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 38 35
Median (Full Range)
Unit of Measure: hours
3.00
(2.00 to 8.00)
4.00
(2.00 to 8.00)
4.Secondary Outcome
Title Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=Number of participants contributing to the mean.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 38 35
Mean (Standard Deviation)
Unit of Measure: hours
85.17  (22.191) 84.18  (20.025)
5.Secondary Outcome
Title Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=Number of participants contributing to the mean.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 37 35
Geometric Mean (Standard Deviation)
Unit of Measure: mL/min
55.76  (25.345) 51.92  (19.655)
6.Secondary Outcome
Title Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=Number of participants contributing to the mean.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 37 35
Geometric Mean (Standard Deviation)
Unit of Measure: liters
397.3  (129.28) 368.1  (102.01)
7.Secondary Outcome
Title Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description Dehydro-aripiprazole is a metabolite of Aripiprazole. 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 - ∞).
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=Number of participants contributing to the mean.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 18 14
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
695.9  (151.95) 685.8  (148.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole 5 mg (Period 1), Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 102.93
Confidence Interval (2-Sided) 90%
94.21 to 112.46
Estimation Comments Values have been back-transformed from the log scale.
8.Secondary Outcome
Title Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 38 35
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
3.007  (1.0889) 3.185  (1.0127)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole 5 mg (Period 1), Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 106.27
Confidence Interval (2-Sided) 90%
100.97 to 111.85
Estimation Comments Values have been back-transformed from the log scale.
9.Secondary Outcome
Title Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description Time for maximum observed plasma concentration.
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 38 35
Median (Full Range)
Unit of Measure: hours
59.9
(23.9 to 120)
71.9
(23.9 to 168)
10.Secondary Outcome
Title Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=Number of participants contributing to the mean.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: hours
97.78  (16.588) 94.27  (16.403)
11.Secondary Outcome
Title Dehydro-aripiprazole (Metabolite) Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf).
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. Data was insufficient for analysis; not analyzable.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Dehydro-aripiprazole (Metabolite) Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. Data was insufficient for analysis; not analyzable.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg
Hide Description Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.
Time Frame Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 38 35
Median (Full Range)
Unit of Measure: ng/mL
0 hour
NA [1] 
(NA to NA)
0.1290
(0.000 to 0.813)
0.5 hour post dose
0.4800
(0.000 to 6.65)
1.220
(0.000 to 7.57)
1 hour post dose
10.69
(0.000 to 26.9)
9.545
(0.167 to 33.1)
2 hours post dose
23.40
(1.07 to 46.7)
21.70
(0.824 to 44.1)
3 hours post dose
21.75
(3.01 to 37.2)
24.40
(8.27 to 36.1)
4 hours post dose
21.35
(5.59 to 35.1)
25.40
(8.85 to 31.9)
6 hours post dose
18.95
(9.96 to 27.9)
20.70
(7.22 to 25.8)
8 hours post dose
16.65
(8.39 to 23.7)
18.00
(7.24 to 23.8)
12 hours post dose
13.65
(6.53 to 23.7)
13.80
(6.46 to 19.2)
16 hours post dose
11.50
(5.73 to 18.2)
12.50
(5.84 to 18.7)
24 hours post dose
10.70
(5.35 to 18.1)
12.20
(5.47 to 18.6)
48 hours post dose
8.310
(3.88 to 14.2)
8.940
(4.64 to 13.5)
72 hours post dose
6.255
(2.46 to 11.6)
6.870
(3.36 to 11.1)
120 hours post dose
3.680
(1.63 to 10.1)
4.000
(1.88 to 7.82)
168 hours post dose
2.390
(0.926 to 16.3)
2.720
(0.872 to 5.53)
216 hours post dose
1.730
(0.491 to 13.4)
1.960
(0.457 to 4.30)
264 hours post dose
1.080
(0.337 to 4.41)
1.340
(0.237 to 3.20)
312 hours post dose
0.8040
(0.202 to 3.99)
1.010
(0.128 to 2.58)
[1]
No observations above the lower limit of quantification.
14.Secondary Outcome
Title Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg
Hide Description Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.
Time Frame Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.
Arm/Group Title Aripiprazole 5 mg (Period 1) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
Overall Number of Participants Analyzed 38 35
Median (Full Range)
Unit of Measure: ng/mL
0 hour
NA [1] 
(NA to NA)
0.1640
(0.000 to 0.871)
0.5 hour post dose
0.0000
(0.0000 to 0.138)
0.2120
(0.000 to 0.950)
1 hour post dose
0.2740
(0.000 to 1.38)
0.5965
(0.000 to 1.64)
2 hours post dose
0.9470
(0.000 to 4.29)
1.240
(0.132 to 2.64)
3 hours post dose
1.260
(0.115 to 5.55)
1.660
(0.473 to 3.33)
4 hours post dose
1.495
(0.277 to 5.38)
1.880
(0.791 to 4.13)
6 hours post dose
1.650
(0.453 to 5.57)
1.910
(0.686 to 4.72)
8 hours post dose
1.780
(0.689 to 5.80)
1.910
(0.686 to 5.29)
12 hours post dose
1.845
(0.748 to 5.35)
1.950
(0.654 to 5.15)
16 hours post dose
2.010
(0.819 to 5.16)
1.970
(0.695 to 4.77)
24 hours post dose
2.520
(1.01 to 6.29)
2.550
(0.952 to 5.68)
48 hours post dose
3.135
(1.26 to 5.79)
3.160
(1.00 to 5.43)
72 hours post dose
2.935
(1.31 to 4.61)
3.020
(1.06 to 6.08)
120 hours post dose
2.440
(1.25 to 4.16)
2.360
(1.14 to 4.16)
168 hours post dose
1.920
(0.996 to 3.76)
1.980
(1.09 to 3.43)
216 hours post dose
1.570
(0.650 to 3.17)
1.460
(0.744 to 2.96)
264 hours post dose
1.080
(0.429 to 3.13)
1.130
(0.454 to 2.57)
312 hours post dose
0.8660
(0.248 to 2.85)
0.9680
(0.252 to 2.10)
[1]
No observations above the lower limit of quantification.
Time Frame Baseline up to Day 27 (follow-up telephone visit)
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
 
Arm/Group Title Aripiprazole 5 mg (Period 1) DVS SR 100 mg (Period 2) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1. DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state). DVS SR as a single oral dose of 100 mg Period 2 / Day 7 though Day 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
All-Cause Mortality
Aripiprazole 5 mg (Period 1) DVS SR 100 mg (Period 2) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole 5 mg (Period 1) DVS SR 100 mg (Period 2) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/36 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aripiprazole 5 mg (Period 1) DVS SR 100 mg (Period 2) Aripiprazole 5 mg + DVS SR 100 mg (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/38 (36.84%)   5/36 (13.89%)   9/35 (25.71%) 
Blood and lymphatic system disorders       
Leukocytosis  1  1/38 (2.63%)  0/36 (0.00%)  0/35 (0.00%) 
Cardiac disorders       
Tachycardia  1  1/38 (2.63%)  0/36 (0.00%)  0/35 (0.00%) 
Gastrointestinal disorders       
Constipation  1  1/38 (2.63%)  1/36 (2.78%)  0/35 (0.00%) 
Lip dry  1  0/38 (0.00%)  1/36 (2.78%)  0/35 (0.00%) 
Nausea  1  6/38 (15.79%)  2/36 (5.56%)  5/35 (14.29%) 
Salivary gland pain  1  1/38 (2.63%)  0/36 (0.00%)  0/35 (0.00%) 
Vomiting  1  3/38 (7.89%)  0/36 (0.00%)  2/35 (5.71%) 
General disorders       
Asthenia  1  1/38 (2.63%)  0/36 (0.00%)  0/35 (0.00%) 
Chills  1  0/38 (0.00%)  0/36 (0.00%)  2/35 (5.71%) 
Infections and infestations       
Escherichia urinary tract infection  1  1/38 (2.63%)  0/36 (0.00%)  0/35 (0.00%) 
Investigations       
Blood creatine phosphokinase increased  1  0/38 (0.00%)  0/36 (0.00%)  1/35 (2.86%) 
Hepatic enzyme increased  1  0/38 (0.00%)  0/36 (0.00%)  1/35 (2.86%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/38 (0.00%)  1/36 (2.78%)  1/35 (2.86%) 
Nervous system disorders       
Dizziness  1  3/38 (7.89%)  0/36 (0.00%)  1/35 (2.86%) 
Dysgeusia  1  0/38 (0.00%)  1/36 (2.78%)  1/35 (2.86%) 
Headache  1  1/38 (2.63%)  2/36 (5.56%)  1/35 (2.86%) 
Paraesthesia  1  0/38 (0.00%)  0/36 (0.00%)  2/35 (5.71%) 
Presyncope  1  2/38 (5.26%)  0/36 (0.00%)  1/35 (2.86%) 
Psychiatric disorders       
Attention deficit / hyperactivity disorder  1  1/38 (2.63%)  0/36 (0.00%)  0/35 (0.00%) 
Insomnia  1  0/38 (0.00%)  0/36 (0.00%)  1/35 (2.86%) 
Vascular disorders       
Flushing  1  1/38 (2.63%)  0/36 (0.00%)  0/35 (0.00%) 
Hot flush  1  7/38 (18.42%)  0/36 (0.00%)  0/35 (0.00%) 
Hypertension  1  1/38 (2.63%)  0/36 (0.00%)  0/35 (0.00%) 
Hypotension  1  1/38 (2.63%)  0/36 (0.00%)  0/35 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01188668     History of Changes
Other Study ID Numbers: B2061026
3151A1-1207
First Submitted: August 24, 2010
First Posted: August 25, 2010
Results First Submitted: September 9, 2011
Results First Posted: October 17, 2011
Last Update Posted: November 7, 2011