Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mutual Pharmaceutical Company, Inc.

ClinicalTrials.gov Identifier:

NCT00806078

First received: December 8, 2008

Last updated: August 22, 2012

Last verified: August 2012

History of Changes

Results First Received: December 18, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Healthy
Intervention:	Drug: quinine sulfate

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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.
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.

Description

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.

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.

Participant Flow for 3 periods

Period 1: First Intervention

	Quinine Alone First	Quinine With Chocolate Pudding First
STARTED	9	9
COMPLETED	9	9
NOT COMPLETED	0	0

Period 2: 7 Day Washout Period

	Quinine Alone First	Quinine With Chocolate Pudding First
STARTED	9	9
COMPLETED	9	9
NOT COMPLETED	0	0

Period 3: Second Intervention

	Quinine Alone First	Quinine With Chocolate Pudding First
STARTED	9	9
COMPLETED	9	9
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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.
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.
Total	Total of all reporting groups

Baseline Measures

	Quinine Alone First	Quinine With Chocolate Pudding First	Total
Number of Participants [units: participants]	9	9	18
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	9	9	18
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	35.5 ± 8.4	35.5 ± 8.4	35.5 ± 8.4
Gender [units: participants]
Female	3	3	6
Male	6	6	12

Outcome Measures

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1. Primary:

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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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2. Primary:

Area Under the Concentration Time Curve From Zero to t. (AUC 0-t) [ Time Frame: 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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Measure Type	Primary
Measure Title	Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)
Measure Description	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.
Time Frame	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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed per protocol

Reporting Groups

	Description
Quinine Alone	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.
Quinine With Chocolate Pudding	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.

Measured Values

	Quinine Alone	Quinine With Chocolate Pudding
Number of Participants Analyzed [units: participants]	18	18
Area Under the Concentration Time Curve From Zero to t. (AUC 0-t) [units: ng·h/mL] Mean ± Standard Deviation	555973.3 ± 15455.81	56008.6 ± 12979.18

No statistical analysis provided for Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)

3. Primary:

The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf) [ Time Frame: 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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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Affairs Director
Organization: Mutual Pharmaceutical Company, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlmutual.com

No publications provided

Responsible Party:	Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT00806078 History of Changes
Other Study ID Numbers:	MPC-001-07-1004
Study First Received:	December 8, 2008
Results First Received:	December 18, 2008
Last Updated:	August 22, 2012
Health Authority:	United States: Food and Drug Administration

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