Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

• 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: Mutual Pharmaceutical Company, Inc.
• Information provided by (Responsible Party): Mutual Pharmaceutical Company, Inc.

Tracking Information

• First Submitted Date: December 8, 2008
• First Posted Date: December 10, 2008
• Results First Submitted Date: December 18, 2008
• Results First Posted Date: July 8, 2009
• Last Update Posted Date: August 31, 2012
• Study Start Date: July 2007
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 7, 2009)

• 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
• 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.
• 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

• Original Primary Outcome Measures (submitted: December 9, 2008): 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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: December 9, 2008): 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 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

Drug: quinine sulfate

2 x 324 mg capsules (648 mg)

Other Name: Qualaquin

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 9, 2008): 18
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2007
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00806078
• Other Study ID Numbers: MPC-001-07-1004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mutual Pharmaceutical Company, Inc.
• Original Responsible Party: Vice President Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
• Current Study Sponsor: Mutual Pharmaceutical Company, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gaetano Morelli, MD; MDS Pharma Services
• Study Chair: Matthew Davis, MD; Mutual Pharmaceutical Company, Inc.

• PRS Account: Mutual Pharmaceutical Company, Inc.
• Verification Date: August 2012