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This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules.
Prior studies have shown that intact quinine sulfate capsules can be taken without regard for food. This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648mg(2 x 324 mg capsules) when opened and mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules. Eighteen healthy adult subjects will be enrolled. Following a fast of at least 10 hours subjects will be randomized to receive either 648 mg of quinine sulfate as the intact capsules or opened mixed in 120ml of chocolate pudding. Following a washout period of at least 7 days all subjects will be given the alternate dose under similar conditions. Following each dose, blood samples will be collected at times sufficient to determine the difference in bioavailability (if any) between the two methods of drug administration. In addition patients will be monitored for any adverse events including Electrocardiogram (EKG) changes (at baseline and 4 hours after each dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single dose intact capsules 2 x 324 mg |
|
| 2 | Experimental | Single dose contents of two capsules (2 x 324 mg) opened and mixed in 120 mL of chocolate pudding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quinine sulfate | Drug | 2 x 324 mg capsules (648 mg) |
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|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods | After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours |
| Area Under the Concentration Time Curve From Zero to t. (AUC 0-t) | The area under the plasma concentration versus time curve from zero to the last measurable plasma concentration as calculated by the linear trapezoidal method. Calculated to determine whether the 2 methods of administration are bioequivalent. | After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours |
| The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf) | AUC inf is calculated as the sum of the AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.It is calculated to evaluate the bioequivalence of the two dosing methods | After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
PR interval on EKG >200 msec at screening or prior to dose in either dosing period
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| Name | Affiliation | Role |
|---|---|---|
| Gaetano Morelli, MD | MDS Pharma Services | Principal Investigator |
| Matthew Davis, MD | Mutual Pharmaceutical Company, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services | Saint Laurent, Montreal | Quebec | H4R 2N6 | Canada |
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| Label | URL |
|---|---|
| Recalls, Market Withdrawals and Safety Alerts | View source |
| Daily Med | View source |
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Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) either as intact capsules or capsules opened and their contents mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Following a 7 day wash out period, all participants were given the alternate dose under similar conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quinine Alone First | Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) as intact capsules after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize quinine pharmacokinetics after this dose. Following a 7 day wash out period, all participants were given quinine 648 mg (2 x 324 mg) as capsules opened and their contents mixed in 120 mL chocolate pudding under similar conditions. |
| FG001 | Quinine With Chocolate Pudding First | Participants were randomized to receive a single dose of Quinine 648 mg (2 x 324 mg capsules) opened and mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose. Following a 7 day wash out period, all participants were given Quinine 648 mg (2 x 324 mg) as intact capsules under similar conditions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| 7 Day Washout Period |
| |||||||||||||
| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quinine Alone First | After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose. |
| BG001 | Quinine With Chocolate Pudding First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) | The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods | Analysis was performed per protocol | Posted | Dec 2008 | Mean | Standard Deviation | ng per mL | After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quinine Alone First | After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling hot | General disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Mutual Pharmaceutical Company, Inc. | 215-697-1743 | clinicaltrials@urlmutual.com |
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| ID | Term |
|---|---|
| D011803 | Quinine |
| ID | Term |
|---|---|
| D002930 | Cinchona Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011812 | Quinuclidines |
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| quinine sulfate | Drug | 2 x 324 mg capsules (648 mg) |
|
|
| NOT COMPLETED |
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| NOT COMPLETED |
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After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
|
|
| Primary | Area Under the Concentration Time Curve From Zero to t. (AUC 0-t) | The area under the plasma concentration versus time curve from zero to the last measurable plasma concentration as calculated by the linear trapezoidal method. Calculated to determine whether the 2 methods of administration are bioequivalent. | Analysis was performed per protocol | Posted | Dec 2008 | Mean | Standard Deviation | ng·h/mL | After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours |
|
|
|
| Primary | The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf) | AUC inf is calculated as the sum of the AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.It is calculated to evaluate the bioequivalence of the two dosing methods | Analysis was performed per protocol | Posted | Jan 2009 | Mean | Standard Deviation | ng-h/ml | After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours |
|
|
|
| 0 |
| 18 |
| 7 |
| 18 |
| EG001 | Quinine With Chocolate Pudding First | After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose. | 0 | 18 | 10 | 18 |
| Dizziness | Nervous system disorders | MeDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
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| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |