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A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg
This study has been completed.
Sponsored by: Mutual Pharmaceutical Company, Inc.
Information provided by: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00726414
  Purpose

A randomized, single-dose, two-way crossover study under fed and fasted conditions in 22 healthy male and female subjects


Condition Intervention Phase
Healthy
Drug: quinine sulfate
Phase I

Drug Information available for: Quinine Quinine bisulfate Quinine hydrochloride Quinine sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Bio-availability Study
Official Title: A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg Under Fasting and Fed Conditions

Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • Bioavailability [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: December 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Two 324mg capsules with 240mL of room temperature water after an overnight fast
Drug: quinine sulfate
two 324mg capsules with water after an overnight fast
B: Active Comparator
Two 324mg capsules with 240mL of room temperature water 30 minutes after initiation of a standardized, high fat breakfast
Drug: quinine sulfate
two 324mg capsules 30 minutes after breakfast

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Screening Demographics: All volunteers selected for this study will be healthy men and women 18 to 45 years of age at the time of dosing. Weight range will not exceed ±20% for height and body frame
  • 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 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
  • Screening Procedures:
  • 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, hepatitis B surface antigen, hepatitis C antibody 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 with spermicide, 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 a 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 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 reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody
  • Volunteers demonstrating a positive drug abuse screen when screened
  • 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 last 4 weeks prior to Period I dosing (as determined by the clinical investigators)
  • 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 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
  • Male volunteers with a QTc> 430msec on the screening ECG or with clinically significant findings
  • Female volunteers with a QTC> 450 msec on the screening ECG or with clinically significant findings
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Mutual Pharmaceutical Company, Inc. ( Matthew Davis, M.D. )
Study ID Numbers: R05-1613
Study First Received: July 30, 2008
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00726414  
Health Authority: United States: Food and Drug Administration

Keywords provided by Mutual Pharmaceutical Company, Inc.:
Bioavailability

Study placed in the following topic categories:
Quinine
Healthy

Additional relevant MeSH terms:
Anti-Infective Agents
Antiprotozoal Agents
Physiological Effects of Drugs
Neuromuscular Agents
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Muscle Relaxants, Central
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009