Trial Outcomes & Findings for Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin (NCT NCT00785980)
NCT ID: NCT00785980
Last Updated: 2012-08-07
Results Overview
The maximum or peak concentration that the drug reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.
Results posted on
2012-08-07
Participant Flow
Twenty-four (24) healthy, non-smoking, adult male and female volunteers from the community at large were enrolled.
Thirty-nine (39) subjects were screened. Four (4) did not meet eligibility criteria, nine (9) had a schedule conflict prior to Period I check-in, and two (2) transferred to another study.
Participant milestones
| Measure |
Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin
All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
|
|---|---|
|
Quinine Sulfate Alone
STARTED
|
24
|
|
Quinine Sulfate Alone
COMPLETED
|
24
|
|
Quinine Sulfate Alone
NOT COMPLETED
|
0
|
|
7 Day Washout Period
STARTED
|
24
|
|
7 Day Washout Period
COMPLETED
|
21
|
|
7 Day Washout Period
NOT COMPLETED
|
3
|
|
Ciprofloxacin Alone
STARTED
|
21
|
|
Ciprofloxacin Alone
COMPLETED
|
21
|
|
Ciprofloxacin Alone
NOT COMPLETED
|
0
|
|
Quinine Sulfate With Ciprofloxacin
STARTED
|
21
|
|
Quinine Sulfate With Ciprofloxacin
COMPLETED
|
21
|
|
Quinine Sulfate With Ciprofloxacin
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin
All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
|
|---|---|
|
7 Day Washout Period
Protocol Violation
|
3
|
Baseline Characteristics
Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin
Baseline characteristics by cohort
| Measure |
Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin
n=24 Participants
All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
25.9 years
STANDARD_DEVIATION 7.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 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
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.Population: Pharmacokinetic analyses are based on twenty-one (21) subjects who successfully completed the study. Three (#3) subjects were dropped by the sponsor due to protocol violation.
The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Quinine Sulfate Alone
n=21 Participants
On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
|
Quinine Sulfate With Ciprofloxacin
n=21 Participants
On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
|
|---|---|---|
|
Maximum Plasma Concentration(Cmax)
|
4,240.65 ng/mL
Standard Deviation 1,162.25
|
4,521.20 ng/mL
Standard Deviation 1,122.28
|
PRIMARY outcome
Timeframe: Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.
Outcome measures
| Measure |
Quinine Sulfate Alone
n=21 Participants
On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
|
Quinine Sulfate With Ciprofloxacin
n=21 Participants
On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
63,415.67 ng-hr/mL
Standard Deviation 16,009.17
|
68,572.17 ng-hr/mL
Standard Deviation 18,922.82
|
PRIMARY outcome
Timeframe: Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.Population: Pharmacokinetic analyses are based on 20 subjects out of the 21 subjects who completed the study. One value was determined to be unreliable and was not used.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Quinine Sulfate Alone
n=20 Participants
On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
|
Quinine Sulfate With Ciprofloxacin
n=20 Participants
On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
|
|---|---|---|
|
Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].
|
67,694.99 ng-hr/mL
Standard Deviation 15,644.74
|
77,439.24 ng-hr/mL
Standard Deviation 26,083.49
|
Adverse Events
Quinine Sulfate Alone
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ciprofloxacin Alone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Quinine Sulfate With Ciprofloxacin
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 |
Quinine Sulfate Alone
n=24 participants at risk
On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period. On Day 11 in the morning, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) following an overnight fast of 10 hours.
|
Ciprofloxacin Alone
n=21 participants at risk
Beginning on Day 8 in the morning and continuing through Day 11 in the evening, all subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice daily for a total of 8 doses.
|
Quinine Sulfate With Ciprofloxacin
n=18 participants at risk
On Day 11 in the morning, all subjects received a dose of quinine sulfate (2 x 324 mg capsules) co-administered with a dose of ciprofloxacin (1 x 500 mg tablet) after an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
8.3%
2/24 • Number of events 2
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/18
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
3/24 • Number of events 3
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
5.6%
1/18 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
5.6%
1/18 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
General disorders
Pain
|
0.00%
0/24
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
5.6%
1/18 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/18
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/18
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 2
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/18
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Nervous system disorders
Dysgeusia
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
5.6%
1/18 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
4.8%
1/21 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
5.6%
1/18 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Nervous system disorders
Tremor
|
0.00%
0/24
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
5.6%
1/18 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/18
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
4.2%
1/24 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/21
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/18
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/24
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
4.8%
1/21 • Number of events 1
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
0.00%
0/18
24 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 24 subjects were administered Quinine sulfate, 21 subjects were administered Ciprofloxacin and 18 subjects were co-administered Quinine Sulfate and Ciprofloxacin.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60