Trial Outcomes & Findings for Drug-Drug Interaction Study Between Quinine Sulfate and Rosiglitazone (NCT NCT00785213)
NCT ID: NCT00785213
Last Updated: 2012-08-07
Results Overview
The maximum or peak concentration that rosiglitazone reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.
Results posted on
2012-08-07
Participant Flow
Twenty-three (23) healthy, non-smoking, adult male and female volunteers from the community at large were enrolled.
Thirty-three (33) subjects were screened. Four (4) did not qualify for the study, four (4) did not finish the screening process and two (2) were transferred to another study.
Participant milestones
| Measure |
Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine
On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
|
|---|---|
|
Rosiglitazone Alone
STARTED
|
23
|
|
Rosiglitazone Alone
COMPLETED
|
23
|
|
Rosiglitazone Alone
NOT COMPLETED
|
0
|
|
2 Day Washout Period
STARTED
|
23
|
|
2 Day Washout Period
COMPLETED
|
23
|
|
2 Day Washout Period
NOT COMPLETED
|
0
|
|
Quinine Sulfate Alone
STARTED
|
23
|
|
Quinine Sulfate Alone
COMPLETED
|
19
|
|
Quinine Sulfate Alone
NOT COMPLETED
|
4
|
|
Rosiglitazone With Quinine Sulfate
STARTED
|
19
|
|
Rosiglitazone With Quinine Sulfate
COMPLETED
|
18
|
|
Rosiglitazone With Quinine Sulfate
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine
On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
|
|---|---|
|
Quinine Sulfate Alone
Adverse Event
|
4
|
|
Rosiglitazone With Quinine Sulfate
Adverse Event
|
1
|
Baseline Characteristics
Drug-Drug Interaction Study Between Quinine Sulfate and Rosiglitazone
Baseline characteristics by cohort
| Measure |
Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine
n=23 Participants
On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
25.61 years
STANDARD_DEVIATION 7.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.Population: Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.
The maximum or peak concentration that rosiglitazone reaches in the plasma.
Outcome measures
| Measure |
Rosiglitazone Alone
n=18 Participants
On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
|
Rosiglitazone With Quinine Sulfate
n=18 Participants
On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Rosiglitazone
|
0.41 ug/mL
Standard Deviation 0.08
|
0.43 ug/mL
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.Population: Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.
The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for rosiglitazone.
Outcome measures
| Measure |
Rosiglitazone Alone
n=18 Participants
On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
|
Rosiglitazone With Quinine Sulfate
n=18 Participants
On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
1.96 ug-hr/mL
Standard Deviation 0.41
|
2.07 ug-hr/mL
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.Population: Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.
The area under the plasma concentration versus time curve from time 0 to infinity. \[AUC(0-∞)\] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for rosiglitazone.
Outcome measures
| Measure |
Rosiglitazone Alone
n=18 Participants
On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
|
Rosiglitazone With Quinine Sulfate
n=18 Participants
On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
1.99 ug-hr/mL
Standard Deviation 0.43
|
2.10 ug-hr/mL
Standard Deviation 0.46
|
Adverse Events
Rosiglitazone Alone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Quinine Sulfate Alone
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Rosiglitazone With Quinine Sulfate
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rosiglitazone Alone
n=23 participants at risk
On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period.
|
Quinine Sulfate Alone
n=23 participants at risk
On Days 4-7, subjects received a dose of quinine sulfate 648 mg (2 x 324 mg capsules) every 8 hours beginning with the 7:15 a.m. dose on Day 4 and continuing through the 11:15 p.m. dose on Day 7.
|
Rosiglitazone With Quinine Sulfate
n=19 participants at risk
On the morning of Day 7, subjects were co-administered a dose of rosiglitazone 4mg and quinine sulfate 648 mg (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
|
Cardiac disorders
Palpitations
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/23
|
43.5%
10/23 • Number of events 15
|
5.3%
1/19 • Number of events 1
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/23
|
17.4%
4/23 • Number of events 4
|
0.00%
0/19
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/23
|
30.4%
7/23 • Number of events 9
|
0.00%
0/19
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/23
|
8.7%
2/23 • Number of events 2
|
0.00%
0/19
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23
|
21.7%
5/23 • Number of events 6
|
10.5%
2/19 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23
|
17.4%
4/23 • Number of events 5
|
0.00%
0/19
|
|
General disorders
Chest pain
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Fatigue
|
0.00%
0/23
|
0.00%
0/23
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Vessel puncture site pain
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/19
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23
|
30.4%
7/23 • Number of events 9
|
10.5%
2/19 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/23
|
13.0%
3/23 • Number of events 3
|
0.00%
0/19
|
|
Nervous system disorders
Headache
|
0.00%
0/23
|
13.0%
3/23 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/23
|
0.00%
0/23
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/23
|
13.0%
3/23 • Number of events 4
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/23
|
0.00%
0/23
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Flushing
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/19
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60