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Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

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ClinicalTrials.gov Identifier: NCT00806078
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : July 8, 2009
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: quinine sulfate Phase 1

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Comparison of the Bioavailability of Quinine Sulfate Capsules Following a 648 mg Dose When Mixed in Chocolate Pudding Relative to That With Intact Capsules in Healthy Adults Under Fasting Conditions
Study Start Date : July 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Single dose intact capsules 2 x 324 mg
 Drug: quinine sulfate
2 x 324 mg capsules (648 mg)
Other Name: Qualaquin
Experimental: 2
Single dose contents of two capsules (2 x 324 mg) opened and mixed in 120 mL of chocolate pudding
 Drug: quinine sulfate
2 x 324 mg capsules (648 mg)
Other Name: Qualaquin


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods

  2. 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 ]
    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.

  3. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy nonsmoking adults with hemoglobin at least 12 g/dl. Males at least 52 kg, females at least 45kg with body mass index in the normal range, females must be chemically or surgically sterile or postmenopausal (amenorrhea at least 2years)

Exclusion Criteria:

  • Pregnant or lactating
  • Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) Recent (1-year) history or evidence of alcoholism or drug abuse History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease, myasthenia gravis, optic neuritis or Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Prolonged corrected QT interval(QTc) on Electrocardiogram(EKG) at screening -males >430 msec, females >450 msec.

PR interval on EKG >200 msec at screening or prior to dose in either dosing period

  • Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose and throughout the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806078


Locations
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Canada, Quebec
MDS Pharma Services
Saint Laurent, Montreal, Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Mutual Pharmaceutical Company, Inc.
Investigators
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Principal Investigator: Gaetano Morelli, MD MDS Pharma Services
Study Chair: Matthew Davis, MD Mutual Pharmaceutical Company, Inc.
More Information
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Additional Information:

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Responsible Party: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00806078    
Other Study ID Numbers: MPC-001-07-1004
First Posted: December 10, 2008    Key Record Dates
Results First Posted: July 8, 2009
Last Update Posted: August 31, 2012
Last Verified: August 2012
Keywords provided by Mutual Pharmaceutical Company, Inc.:
Healthy
Bioequivalence
Pharmacokinetics
Additional relevant MeSH terms:
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Quinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscle Relaxants, Central
 Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents