A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions
Condition: Healthy
Intervention: Quinine Sulfate Capsules 324 mg; Quinine Sulphate Tablets 300 mg; Quinine Sulfate Capsules 324 mg
Intervention description: One 324 mg capsule administered after an overnight fast of at least 10 hours.; One 300 mg tablet administered after an overnight fast of at least 10 hours.; One 324 mg capsule administered thirty minutes after the initiation of a standardized, high-fat breakfast.
Intervention MeSH terms: Quinine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
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 relative bioavailability of Quinine
      Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine
      Sulphate 300 mg tablets, manufactured by the Government Pharmaceutical Organization, Bangkok
      Metropolis, Thailand, after single oral dose administration under fasting conditions. An
      additional purpose of this study is to evaluate the effect of food on the Mutual
      Pharmaceutical Company product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening Demographics: All volunteers selected for this study will be healthy men or
             women at least 18 years of age, inclusive, at the 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 the screening evaluation and
             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 an
             evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous
             systems.

          -  The screening clinical laboratory procedures will include:

          -  HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet
             count

          -  CLINICAL CHEMISTRY:serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), 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 2 years; 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 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 history of 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 150mL 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 QTc >480 msec on the screening electrocardiogram (ECG) or with
             clinically significant findings

          -  Volunteers who have a glucose-6-phosphate dehydrogenese deficiency (G6PD)