HealthyPhase 1NCT00726895
A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions
A Phase 1 study testing Quinine Sulfate Capsules 324 mg in people with Healthy, run by Mutual Pharmaceutical Company, Inc..
Trial summary
The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Quinine Sulfate Capsules 324 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Jun 2004
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 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 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, 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;
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- 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)
Who cannot join
- 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
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- 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 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 with a QTc (corrected QT interval) > 480 msec on the screening electrocardiogram (ECG) or with clinically significant findings
- Volunteers who have a glucose-6-phosphate dehydrogenese deficiency (G6PD)
About this study
Official title: A Randomized, Two-way Crossover Design Used to Compare the Dose Proportionality of Quinine Sulfate Capsules, 324 mg Following a Single Oral Dose of 1 x 324 mg Capsule Versus 2 x 324 mg Capsules in Healthy Adult Volunteers
The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions.
Read the detailed description
The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions.
Twenty-four healthy, non-smoking, non-obese, male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two Quinine Sulfate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of treatment A, Quinine Sulfate 1 x 324 mg capsule, or a single oral dose of treatment B, Quinine Sulfate 2 x 324 mg capsules. After a 7 day washout period,on the morning of Day 8 following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Quinine Sulfate. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following each dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.
- Conditions
- Healthy
- Being tested
- Quinine Sulfate Capsules 324 mg
- Keywords
- Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinine Sulfate Capsules 324 mgDrug
1 x 324 mg capsule
Quinine Sulfate Capsules 324 mgDrug
2 x 324 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Quinine Sulfate Capsules 1 x 324 mg Dose | Experimental | Quinine Sulfate 1 x 324 mg capsule dose. Receives: Drug: Quinine Sulfate Capsules 324 mg |
| Quinine Sulfate Capsules 2 x 324 mg Dose | Experimental | Quinine Sulfate 2 x 324 mg capsules dose. Receives: Drug: Quinine Sulfate Capsules 324 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that the drug reaches in the plasma.
Measured: 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)]
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.
Measured: 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-∞)]
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startMay 2004
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726895
- Sponsor's protocol ID
- R04-0376
- Status last verified
- Jan 2010
- First submitted
- 30 Jul 2008
- Last updated
- 20 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-way Crossover Design Used to Compare the Dose Proportionality of Quinine Sulfate Capsules, 324 mg Following a Single Oral Dose of 1 x 324 mg Capsule Versus 2 x 324 mg Capsules in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00726895
- Acronym / sponsor ID
- R04-0376
- Conditions
- Healthy
- Keywords
- Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Posted 30 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions.
Detailed description
The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions.
Twenty-four healthy, non-smoking, non-obese, male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two Quinine Sulfate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of treatment A, Quinine Sulfate 1 x 324 mg capsule, or a single oral dose of treatment B, Quinine Sulfate 2 x 324 mg capsules. After a 7 day washout period,on the morning of Day 8 following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Quinine Sulfate. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following each dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quinine Sulfate Capsules 1 x 324 mg Dose | Experimental | Drug: Quinine Sulfate Capsules 324 mgQuinine Sulfate 1 x 324 mg capsule dose. |
| Quinine Sulfate Capsules 2 x 324 mg Dose | Experimental | Drug: Quinine Sulfate Capsules 324 mgQuinine Sulfate 2 x 324 mg capsules dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 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 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, white blood cell (WBC) count with differential, red blood cell (RBC) count, platelet count;
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quinine Sulfate Capsules 324 mg1 x 324 mg capsule | Drug | Quinine Sulfate Capsules 1 x 324 mg Dose |
| Quinine Sulfate Capsules 324 mg2 x 324 mg capsules | Drug | Quinine Sulfate Capsules 2 x 324 mg Dose |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 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.
The maximum or peak concentration that the drug reaches in the plasma.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Time frame: 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.
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.
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quinine Sulfate Capsules 324 mg in people with Healthy, run by Mutual Pharmaceutical Company, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.