HealthyPhase 1NCT03280095
Bioequivalence Study of Co-codamol 15mg/500mg Capsules vs Co-codamol 30mg/500mg Tablets in Healthy Subjects
A Phase 1 study testing co-codamol 15mg/500mg capsule and co-codamol 30mg/500mg tablet in people with Healthy, run by Galen Limited at 1 site in United Kingdom.
Trial summary
The purpose of this study is to compare the bioavailability of co-codamol 15mg/500mg capsules (test product) and co-codamol 30mg/500mg tablets (reference product). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- co-codamol 15mg/500mg capsule and co-codamol 30mg/500mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2014to 12 Dec 2014
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers aged 18-45 (both inclusive), as determined by medical history, physical examination, laboratory test values, vital signs and 12-lead ECGs at screening.
- Non-smokers from at least three months before receiving the first dose of study drug and for the duration of the study.
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Able to voluntarily provide written informed consent to participate in the study.
- Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol, as confirmed during the informed consent process.
- Female volunteers of child-bearing potential and less than one year postmenopausal must have a negative serum pregnancy test and be non-lactating.
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- Female volunteers who have been post-menopausal for more than one year and have elevated serum follicle stimulating hormone (FSH) or are treated with hormone replacement therapy (HRT) or female volunteers who have been permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy).
- Male volunteers and female volunteers of child-bearing potential who are sexually active must use two highly effective methods of contraception with their partners throughout the study and for 30 days after completion of the study (female volunteers) or 90 days after completion of the study (male volunteers). Acceptable methods include: condom or occlusive cap (diaphragm or cervical/ vault caps) with spermicidal foam/ gel/ film/ cream/ suppository; male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); established use of oral, injected or implanted hormonal methods of contraception and placement of an intrauterine device or intrauterine system. True abstinence is an acceptable method only where this is already established as the volunteer's preferred and usual lifestyle.
- Male volunteers must not donate sperm during the study and for 90 days after completion of the study.
- Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
- The volunteer's primary care physician has confirmed within the last 12 months that there is nothing in their medical history that would preclude their enrolment into a clinical study.
- Volunteers should be cautioned that codeine may impair mental and/or physical abilities, therefore it may affect their ability to drive or operate machinery for up to approximately 24 hours post-dose.
Who cannot join
- Volunteers with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, urogenital (including benign prostatic hypertrophy), haematological, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or current infection.
- Laboratory values at screening which are deemed to be clinically significant, unless agreed in advance by the Sponsor's Medical Representative and Principal Investigator.
- Female volunteers who are pregnant or lactating.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Current or history of drug or alcohol abuse or a positive drugs of abuse or alcohol test at screening or check-in.
- Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
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- Any clinically significant illness within 30 days prior to study drug administration.
- Donation of blood or blood products within 90 days prior to study drug administration, or at any time during the study, except as required by this protocol.
- Volunteers who have a history or presence of any significant drug allergy, including a history of hypersensitivity to paracetamol, codeine phosphate hemihydrate, any related drugs, or any of the excipients contained in the formulations.
- Use of any prescription or over-the-counter medication (including vitamins, herbal and mineral supplements) within 14 days prior to study drug administration until the end of the study, with the exception of Investigator approved contraceptives and HRT.
- Volunteers with inadequate venous access to allow collection of blood samples as required by this protocol.
- Strenuous exercise, as judged by the Investigator, within 72 hours prior to screening, within 72 hours prior to study drug administration and for the duration of the study until after the post-study medical.
- Weekly alcohol intake exceeding the equivalent of 14 units per week for females or 21 units per week for males.
- Consumption of alcoholic beverages within 48 hours prior to study drug administration and during study confinement.
- Consumption of caffeine or xanthine-containing products within 24 hours prior to study drug administration and during study confinement.
- Consumption of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit or Seville oranges within 7 days prior to study drug administration, during study confinement and during the wash-out periods.
- Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-label, Three-treatment, Single Dose, Crossover Study Investigating the Bioequivalence of Co-codamol 15/500mg Capsules With a Co-codamol 30/500mg Tablet in Healthy Subjects Under Fasting Conditions
The purpose of this study is to compare the bioavailability of co-codamol 15mg/500mg capsules (test product) and co-codamol 30mg/500mg tablets (reference product).
- Conditions
- Healthy
- Being tested
- co-codamol 15mg/500mg capsule, co-codamol 30mg/500mg tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co-codamol 15mg/500mg capsuleDrug
co-codamol 30mg/500mg tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | One capsule of test product (co-codamol 15mg/500mg capsule) containing 15mg codeine phosphate hemihydrate and 500mg paracetamol. Receives: Drug: co-codamol 15mg/500mg capsule |
| Treatment 2 | Experimental | Two capsules of test product (co-codamol 15mg/500mg capsule), each containing 15mg codeine phosphate hemihydrate and 500mg paracetamol (i.e. a total dose of 30mg codeine phosphate hemihydrate and 1000mg paracetamol). Receives: Drug: co-codamol 15mg/500mg capsule |
| Treatment 3 | Active comparator | One tablet of reference product (co-codamol 30mg/500mg tablet) containing 30mg codeine phosphate hemihydrate and 500mg paracetamol. Receives: Drug: co-codamol 30mg/500mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum measurable plasma concentration (Cmax)
Cmax and AUC0-t will be used to calculate bioequivalence of the test product (Treatment 1) vs reference product (Treatment 3) for paracetamol, and test product (Treatment 2) vs reference product (Treatment 3) for codeine.
Measured: 0 to 36 hours post-dose
Area under the plasma concentration versus time curve from drug administration to last observed concentration at time t (AUC0-t)
Cmax and AUC0-t will be used to calculate bioequivalence of the test product (Treatment 1) vs reference product (Treatment 3) for paracetamol, and test product (Treatment 2) vs reference product (Treatment 3) for codeine.
Measured: 0 to 36 hours post-dose
Secondary outcomes (5)
Adverse events, including laboratory parameters.
The safety of volunteers will be monitored by recording adverse events, including laboratory parameters.
Measured: 23 days
Time of maximum measured plasma concentration (Tmax)
The pharmacokinetic parameter Tmax will be measured for test and reference products.
Measured: 0 to 36 hours post-dose
Elimination rate constant (Kel)
The pharmacokinetic parameter Kel will be measured for test and reference products.
Measured: 0 to 36 hours post-dose
Elimination or terminal half-life (t1/2)
The pharmacokinetic parameter t1/2 will be measured for test and reference products.
Measured: 0 to 36 hours post-dose
Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-∞)
The pharmacokinetic parameter AUC0-∞ will be measured for test and reference products.
Measured: 0 to 36 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start23 Sep 2014
- Primary completion12 Dec 2014
- Study completion12 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galen Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bell, MD, Principal investigator, BioKinetic Europe Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280095
- Sponsor's protocol ID
- BKE12814
- Other IDs
- 2014-003334-12, 2014
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, Three-treatment, Single Dose, Crossover Study Investigating the Bioequivalence of Co-codamol 15/500mg Capsules With a Co-codamol 30/500mg Tablet in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03280095
- Acronym / sponsor ID
- BKE12814
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Galen LimitedIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2014 (actual)
- Primary completion
- 12 Dec 2014 (actual)
- Study completion
- 12 Dec 2014 (actual)
- First posted
- 12 Sep 2017 (actual)
- 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.
The purpose of this study is to compare the bioavailability of co-codamol 15mg/500mg capsules (test product) and co-codamol 30mg/500mg tablets (reference product).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: co-codamol 15mg/500mg capsuleOne capsule of test product (co-codamol 15mg/500mg capsule) containing 15mg codeine phosphate hemihydrate and 500mg paracetamol. |
| Treatment 2 | Experimental | Drug: co-codamol 15mg/500mg capsuleTwo capsules of test product (co-codamol 15mg/500mg capsule), each containing 15mg codeine phosphate hemihydrate and 500mg paracetamol (i.e. a total dose of 30mg codeine phosphate hemihydrate and 1000mg paracetamol). |
| Treatment 3 | Active comparator | Drug: co-codamol 30mg/500mg tabletOne tablet of reference product (co-codamol 30mg/500mg tablet) containing 30mg codeine phosphate hemihydrate and 500mg paracetamol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male and female volunteers aged 18-45 (both inclusive), as determined by medical history, physical examination, laboratory test values, vital signs and 12-lead ECGs at screening.
- Non-smokers from at least three months before receiving the first dose of study drug and for the duration of the study.
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Able to voluntarily provide written informed consent to participate in the study.
- Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol, as confirmed during the informed consent process.
Key exclusion criteria (17 listed)
- Volunteers with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, urogenital (including benign prostatic hypertrophy), haematological, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or current infection.
- Laboratory values at screening which are deemed to be clinically significant, unless agreed in advance by the Sponsor's Medical Representative and Principal Investigator.
- Female volunteers who are pregnant or lactating.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Current or history of drug or alcohol abuse or a positive drugs of abuse or alcohol test at screening or check-in.
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 |
|---|---|---|
| co-codamol 15mg/500mg capsule | Drug | Treatment 1, Treatment 2 |
| co-codamol 30mg/500mg tablet | Drug | Treatment 3 |
Primary outcome
Maximum measurable plasma concentration (Cmax)
Time frame: 0 to 36 hours post-dose
Cmax and AUC0-t will be used to calculate bioequivalence of the test product (Treatment 1) vs reference product (Treatment 3) for paracetamol, and test product (Treatment 2) vs reference product (Treatment 3) for codeine.
Area under the plasma concentration versus time curve from drug administration to last observed concentration at time t (AUC0-t)
Time frame: 0 to 36 hours post-dose
Cmax and AUC0-t will be used to calculate bioequivalence of the test product (Treatment 1) vs reference product (Treatment 3) for paracetamol, and test product (Treatment 2) vs reference product (Treatment 3) for codeine.
5 secondary outcomes
Adverse events, including laboratory parameters.
Time frame: 23 days
Time of maximum measured plasma concentration (Tmax)
Time frame: 0 to 36 hours post-dose
Elimination rate constant (Kel)
Time frame: 0 to 36 hours post-dose
Elimination or terminal half-life (t1/2)
Time frame: 0 to 36 hours post-dose
Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: 0 to 36 hours post-dose
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 12 Sep 2017.
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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.
David Bell, MD principal investigator
BioKinetic Europe Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing co-codamol 15mg/500mg capsule and co-codamol 30mg/500mg tablet in people with Healthy, run by Galen Limited at 1 site in United Kingdom.
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 12 inclusion and 17 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 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Maximum measurable plasma concentration (Cmax) (time frame: 0 to 36 hours post-dose). The study lists 2 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 12 Sep 2017.