Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution StudiesPhase 1NCT02095704
Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers
A Phase 1 study testing paracetamol oral solution and paracetamol tablet in people with Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution Studies, run by Central South University.
Trial summary
Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an orally administered solid dosage form. The aim of this study was to evaluate the pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution Studies
- What is being tested?
- paracetamol oral solution and paracetamol tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- May 2013to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex: Male or female (limited to PK study)
- Healthy volunteers, age: 18-45（medical history, physical examination, vital signs, ECG and lab tests are qualified during screening）
- Body Mass Index（BMI）:19~24 or body weight is not less than 50Kg
- Non-pregnant women confirmed by pregnancy test
- Vital Signs: after 3 minutes supination, the following measurements criteria should be within ranges: body temperature (axillary temperature), 36.0~37.0 ℃; blood pressure, SBP 90~140mmHg（12.0~18.7kpa）and DBP 60~90mmHg（8.0~12.0kpa）; arterial pulse: 60~100 bpm
- Non-hypersensitivity to this product or its similar product
Show all 9Show fewer
- Non-smoker, non-alcoholic
- Subject must be able to sign Inform Consent prior to participation into this study
- Subject must be able to communicate with investigator and comply with study protocol.
Who cannot join
- Subjects meet with one or several of the following criteria should be excluded:
- Subjects failed in physical examination
- Pregnant or nursing women
- Administration of a known drug that can cause damage to organs within 3 months
- Administration of any prescription drug or non-prescription drug 2 weeks before initial dose
- Before initial dose, participation in any other clinical trials within 3 months
Show all 25Show fewer
- Blood donation 3 months before this study, or plan to have blood donation during or one month after this study
- Diagnosis of clinical evident diseases 2 weeks before initial dose
- Primary diseases to vital organs
- Physically or mentally disabled
- Medical history of specific allergy (asthma, measles, eczematous dermatitis), or known to allergic to similar (including excipients)
- Any other surgical or internal medicinal conditions that might cause damage to study subjects or will change the absorption, distribution, metabolism and elimination of investigational drug, including:
- inflammatory intestinal syndrome, peptic ulcer, alimentary tract hemorrhage
- a history of severe gastrointestinal tract operation, such as gastrectomy, gastrosmoty / jejunostomy or large bowel resection
- a history of hepatic disease or laboratory examination findings such as ALT, AST, γ-GT or T-Bili showing clinically significant abnormalities to liver
- a history of renal disease or laboratory examination findings such as creatinine, urea nitrogen, or albuminuria showing clinically significant abnormalities to kidney
- urination disorder or dysuresia.
- A history of immunological deficiency disease, or HIV positive
- HBV or HCV positive
- Women undergone menstrual period during study
- Consumption of a significant amount of smoking or drinking, that is drinking more than 28 units of alcohol per week (1 unit: 285ml of beer, 25ml of liquor, or 1 glass of wine), or smoking more than 2 cigarettes
- Frequent use of sedatives, hypnotics, stabilizers or other addictive drugs
- Consumption of more than 8 cups of tea, coffee, and or caffeine beverages
- Unable to complete this study for any others reasons.
- Investigators.
About this study
Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an orally administered solid dosage form. The aim of this study was to evaluate the pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics parameters, investigators trend to propose a method to estimate in vivo dissolution time and dissolution kinetics of solid dosage form.
- Being tested
- paracetamol oral solution, paracetamol tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamol oral solutionDrug
dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose
paracetamol tabletDrug
dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose
| Study group | Role | What they receive |
|---|---|---|
| paracetamol oral solution | Experimental | dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose Receives: Drug: paracetamol oral solution |
| paracetamol tablet | Experimental | dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose Receives: Drug: paracetamol tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
AUC:the area under the concentration-time curve
Measured: one month
Cmax
Cmax: maximum plasma concentration
Measured: one month
Tmax
Tmax: the time point of maximum plasma concentration
Measured: one month
MRT
MRT: mean residence time
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution StudiesStudies 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
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feifan Xie, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095704
- Sponsor's protocol ID
- CSU-YXY-001
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02095704
- Acronym / sponsor ID
- CSU-YXY-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an orally administered solid dosage form. The aim of this study was to evaluate the pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics parameters, investigators trend to propose a method to estimate in vivo dissolution time and dissolution kinetics of solid dosage form.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paracetamol oral solution | Experimental | Drug: paracetamol oral solutiondosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose |
| paracetamol tablet | Experimental | Drug: paracetamol tabletdosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Sex: Male or female (limited to PK study)
- Healthy volunteers, age: 18-45（medical history, physical examination, vital signs, ECG and lab tests are qualified during screening）
- Body Mass Index（BMI）:19~24 or body weight is not less than 50Kg
- Non-pregnant women confirmed by pregnancy test
- Vital Signs: after 3 minutes supination, the following measurements criteria should be within ranges: body temperature (axillary temperature), 36.0~37.0 ℃; blood pressure, SBP 90~140mmHg（12.0~18.7kpa）and DBP 60~90mmHg（8.0~12.0kpa）; arterial pulse: 60~100 bpm
Key exclusion criteria (25 listed)
- Subjects failed in physical examination
- Pregnant or nursing women
- Administration of a known drug that can cause damage to organs within 3 months
- Administration of any prescription drug or non-prescription drug 2 weeks before initial dose
- Before initial dose, participation in any other clinical trials within 3 months
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 |
|---|---|---|
| paracetamol oral solutiondosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose | Drug | paracetamol oral solution |
| paracetamol tabletdosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose | Drug | paracetamol tablet |
Primary outcome
AUC
Time frame: one month
AUC:the area under the concentration-time curve
Cmax
Time frame: one month
Cmax: maximum plasma concentration
Tmax
Time frame: one month
Tmax: the time point of maximum plasma concentration
MRT
Time frame: one month
MRT: mean residence time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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 paracetamol oral solution and paracetamol tablet in people with Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution Studies, run by Central South University.
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 9 inclusion and 25 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 26 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC (time frame: one month). The study lists 4 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 26 Mar 2014.