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
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.

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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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.
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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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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