Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

NCT00806078 | Completed Phase 1 Results

• 1 other identifier: MPC-001-07-1004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules.

Conditions

Healthy

Keywords

Healthy; Bioequivalence; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods

  After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours

• Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)

  The area under the plasma concentration versus time curve from zero to the last measurable plasma concentration as calculated by the linear trapezoidal method. Calculated to determine whether the 2 methods of administration are bioequivalent.

  After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours

• The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf)

  AUC inf is calculated as the sum of the AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.It is calculated to evaluate the bioequivalence of the two dosing methods

  After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours

Study Arms (2)

1

EXPERIMENTAL

Single dose intact capsules 2 x 324 mg

Drug: quinine sulfate

2

EXPERIMENTAL

Single dose contents of two capsules (2 x 324 mg) opened and mixed in 120 mL of chocolate pudding

Drug: quinine sulfate

Interventions

quinine sulfate DRUG

2 x 324 mg capsules (648 mg)

Also known as: Qualaquin

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy nonsmoking adults with hemoglobin at least 12 g/dl. Males at least 52 kg, females at least 45kg with body mass index in the normal range, females must be chemically or surgically sterile or postmenopausal (amenorrhea at least 2years)

You may not qualify if:

• Pregnant or lactating
• Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) Recent (1-year) history or evidence of alcoholism or drug abuse History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease, myasthenia gravis, optic neuritis or Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Prolonged corrected QT interval(QTc) on Electrocardiogram(EKG) at screening -males \>430 msec, females \>450 msec.
• PR interval on EKG \>200 msec at screening or prior to dose in either dosing period
• Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose and throughout the study

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Study Sites (1)

MDS Pharma Services

Saint Laurent, Montreal, Quebec, H4R 2N6, Canada

Location

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med

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 Affairs Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• Gaetano Morelli, MD

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

• Matthew Davis, MD

  Mutual Pharmaceutical Company, Inc.

  STUDY CHAIR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 10, 2008
• Study Start: July 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: August 31, 2012
• Results First Posted: July 8, 2009

Record last verified: 2012-08

Locations

CA (1)