A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions

NCT00727272 | Completed Phase 1 Results

• 1 other identifier: RA3-085
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bioavailability

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  The maximum or peak concentration that the drug reaches in the plasma.

  serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.

• Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

  The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.

  serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.

• Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]

  The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.

  serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.

Study Arms (3)

Quinine Sulfate Caps 324 mg - Fasting

EXPERIMENTAL

A single dose of quinine sulfate 324 mg administered with 240 mL of room temperature water after an overnight fast of at least 10 hours.

Drug: Quinine Sulfate Capsules 324 mg

Quinine Sulphate Tabs 300 mg - Fasting

EXPERIMENTAL

A single dose of quinine sulphate 300 mg administered with 240 mL of room temperature water after an overnight fast of at least 10 hours.

Drug: Quinine Sulphate Tablets 300 mg

Quinine Sulfate Caps 324 mg - Fed

EXPERIMENTAL

A single dose of quinine sulfate 324 mg administered with 240 mL of room temperature water thirty minutes after the initiation of a standardized, high-fat breakfast.

Drug: Quinine Sulfate Capsules 324 mg

Interventions

Quinine Sulfate Capsules 324 mg DRUG

One 324 mg capsule administered after an overnight fast of at least 10 hours.

Quinine Sulfate Caps 324 mg - Fasting

Quinine Sulphate Tablets 300 mg DRUG

One 300 mg tablet administered after an overnight fast of at least 10 hours.

Quinine Sulphate Tabs 300 mg - Fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Study Sites (1)

PRACS

Fargo, North Dakota, 56721, United States

Location

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med - Posting of Recently Submitted Labeling to the FDA

MeSH Terms

Interventions

Quinine

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• James D Carlson, Pharm.D.

  PRACS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: February 1, 2004
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: January 20, 2010
• Results First Posted: December 30, 2009

Record last verified: 2010-01

Locations

US (1)