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

December 8, 2008
August 22, 2012
July 2007
August 2007   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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
Pharmacokinetic parameters for plasma quinine including Cmax, Tmax, Kel , T 1/2, AUC 0-t, AUCinf, AUC/AUCinf will be calculated to determine whether the 2 methods of administration are bioequivalent. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00806078 on ClinicalTrials.gov Archive Site
Not Provided
Adverse events including EKG changes from baseline, that occur after dosing will be recorded and reported to CRF with severity and judgement of likely causality by the investigator. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
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

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).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: quinine sulfate
2 x 324 mg capsules (648 mg)
Other Name: Qualaquin
  • Experimental: 1
    Single dose intact capsules 2 x 324 mg
    Intervention: Drug: quinine sulfate
  • Experimental: 2
    Single dose contents of two capsules (2 x 324 mg) opened and mixed in 120 mL of chocolate pudding
    Intervention: Drug: quinine sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00806078
MPC-001-07-1004
No
Mutual Pharmaceutical Company, Inc.
Mutual Pharmaceutical Company, Inc.
Not Provided
Principal Investigator: Gaetano Morelli, MD MDS Pharma Services
Study Chair: Matthew Davis, MD Mutual Pharmaceutical Company, Inc.
Mutual Pharmaceutical Company, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP