Phase 1 Completed N=18 Randomized Basic Science

Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

Healthy

Source: ClinicalTrials.gov NCT00806078 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2009

Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 3291.411; 3439.867 ng per mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Observed Plasma Concentration (Cmax)	3291.411; 3439.867	—
PRIMARY Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)	555973.3; 56008.6	—
PRIMARY The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf)	61887.4; 60764.9	—

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

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Data sourced from ClinicalTrials.gov (NCT00806078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.