Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: quinine sulfate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: 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 |
- 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
| Enrollment: | 18 |
| Study Start Date: | July 2007 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Canada, Quebec | |
| MDS Pharma Services | |
| Saint Laurent, Montreal, Quebec, Canada, H4R 2N6 | |
| Principal Investigator: | Gaetano Morelli, MD | MDS Pharma Services |
| Study Chair: | Matthew Davis, MD | Mutual Pharmaceutical Company, Inc. |
More Information
Additional Information:
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 |
Keywords provided by Mutual Pharmaceutical Company, Inc.:
|
Healthy Bioequivalence Pharmacokinetics |
Additional relevant MeSH terms:
|
Quinine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Muscle Relaxants, Central |
Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on June 18, 2013