A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg

NCT00726414 | Completed Phase 1 Results

• 1 other identifier: R05-1613
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.

Conditions

Healthy

Keywords

Bioavailability

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) for Quinine Sulfate

  The maximum or peak concentration that Quinine Sulfate reaches in the plasma.

  serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) 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 drug administration.

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

  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 plasma concentrations were drawn prior to dose administration (0 hour) 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 drug administration.

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

  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 plasma concentrations were drawn prior to dose administration (0 hour) 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 drug administration.

Study Arms (2)

Quinine Sulfate Capsules 2 x 324 mg Capsules - Fasting

EXPERIMENTAL

A single dose of Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours.

Drug: Quinine Sulfate 2 x 324 mg Capsules

Quinine Sulfate Capsules 2 x 324 mg Capsules - Fed

EXPERIMENTAL

A single dose of Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.

Drug: Quinine Sulfate 2 x 324 mg Capsules

Interventions

Quinine Sulfate 2 x 324 mg Capsules DRUG

Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours.

Quinine Sulfate Capsules 2 x 324 mg Capsules - Fasting

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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 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, 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, 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, intrauterine device (IUD), or abstinence; or
• is postmenopausal for at least 1 year; 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 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

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Results Point of Contact

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

clinicaltrials@urlmutual.com

215-697-1743

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: December 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: February 3, 2010
• Results First Posted: February 3, 2010

Record last verified: 2010-01