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A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions
This study has been completed.
Sponsored by: Mutual Pharmaceutical Company, Inc.
Information provided by: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00726895
  Purpose

This study will compare the dose proportionality of 324mg Quinine Sulfate Capsules following a single oral dose (1 x 324mg capsule vs. 2 x 324mg capsules) in healthy adult volunteers when administered under fasting conditions


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, Single Blind (Subject), Single Group Assignment, Bio-availability Study
Official Title: A Randomized, Two-Way Crossover Design Used to Compare the Dose Proportionality of Quinine Sulfate Capsules USP, 324mg Following a Single Oral Dose of 1 x 324mg Capsule Versus 2 x 324mg Capsules in Healthy Adult Volunteers

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

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

Enrollment: 24
Study Start Date: May 2004
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
One 324mg capsule administered under fasting conditions
Drug: quinine sulfate
1 x 324mg capsule
B: Active Comparator
Two 324mg capsules administered under fasting conditions
Drug: quinine sulfate
2 x 324mg capsules

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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, 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 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 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.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 > 480 msec on the screening ECG or with clinically significant findings
  • Volunteers who have a glucose-6-phosphate dehydrogenese deficiency (G6PD)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Mutual Pharmaceutical ( Matthew W. Davis, MD, )
Study ID Numbers: R04-0376
Study First Received: July 30, 2008
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00726895  
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