A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions
Condition: Healthy
Intervention: Quinine Sulfate Capsules 324 mg; Quinine Sulfate Capsules 324 mg
Intervention description: 1 x 324 mg capsule; 2 x 324 mg capsules
Intervention MeSH terms: Quinine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioavailability

Summary:

      The purpose of this study is to evaluate and compare the dose proportionality of 324 mg
      Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg
      capsules) in healthy adult volunteers when administered under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening Demographics: All volunteers will be healthy men or women 18 years of age or
             older at the time of dosing. The weight range will not exceed ±20% for height and body
             frame as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table

          -  Screening procedures: Each volunteer will complete the screening process within 28
             days prior to Period I dosing. Consent documents for both screening evaluation and
             human immunodeficiency virus (HIV) antibody determination will be reviewed, discussed,
             and signed by each potential participant before full implementation of screening
             procedures

          -  Screening will include general observations, physical examination, demographics,
             medical and medication history, an electrocardiogram, sitting blood pressure and heart
             rate, respiratory rate and temperature. The physical examination will include, but may
             not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory
             and central nervous systems.

          -  The screening clinical laboratory procedures will include:

          -  HEMATOLOGY: hematocrit, hemoglobin, white blood cell (WBC) count with differential,
             red blood cell (RBC) count, platelet count;

          -  CLINICAL CHEMISTRY: serum creatinine, blood urea nitrogen (BUN), glucose, AST(SGOT -
             Serum glutamic-oxaloacetic transaminase), ALT(SGPT - Serum glutamic-pyruvic
             transaminase), albumin, total bilirubin, total protein, and alkaline phosphatase;

          -  HIV antibody and hepatitis B surface antigen screens;

          -  URINALYSIS: by dipstick; full microscopic examination if dipstick positive; and

          -  URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines,
             cannabinoids, cocaine metabolites, opiates and phencyclidine

          -  SERUM PREGNANCY SCREEN (female volunteers only)

        If female and:

          -  of childbearing potential, is practicing an acceptable method of birth control for the
             duration of the study as judged by the investigator(s), such as condom with
             spermicide, diaphragm, intrauterine device (IUD), or abstinence; or

          -  is postmenopausal for at least 1 year; or is surgically sterile (bilateral tubal
             ligation, bilateral oophorectomy, or hysterectomy)

        Exclusion Criteria:

          -  Volunteers with a recent history of drug or alcohol addiction or abuse

          -  Volunteers with the presence of a clinically significant disorder involving the
             cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
             endocrine, or neurologic system(s) or psychiatric disease (as determined by the
             clinical investigators)

          -  Volunteers whose clinical laboratory test values are outside the accepted reference
             range and when confirmed on re-examination are deemed to be clinically significant

          -  Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive
             HIV antibody screen

          -  Volunteers demonstrating a positive drug abuse screen when screened for this study

          -  Female volunteers demonstrating a positive pregnancy screen

          -  Female volunteers who are currently breastfeeding

          -  Volunteers with a history of allergic response(s) to quinine or related drugs

          -  Volunteers with a history of clinically significant allergies including drug allergies

          -  Volunteers with a clinically significant illness during the 4 weeks prior to Period I
             dosing (as determined by the clinical investigators)

          -  Volunteers who currently use tobacco products

          -  Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism
             in the 28 days prior to Period I dosing

          -  Volunteers who report donating greater than 150 mL of blood within 28 days prior to
             Period I dosing. All subjects will be advised not to donate blood for four weeks after
             completing the study

          -  Volunteers who have donated plasma (e.g.plasmapheresis) within 14 days prior to Period
             I dosing. All subjects will be advised not to donate plasma for four weeks after
             completing the study

          -  Volunteers who report receiving any investigational drug within 28 days prior to
             Period I dosing

          -  Volunteers who report taking any systemic prescription medication in the 14 days prior
             to Period I dosing

          -  Volunteers with a QTc (corrected QT interval) > 480 msec on the screening
             electrocardiogram (ECG) or with clinically significant findings

          -  Volunteers who have a glucose-6-phosphate dehydrogenese deficiency (G6PD)