FastingPhase 1NCT02599337
Bioequivalence Study of Sorafenib Tablet and Nexavar
A Phase 1 study testing Nexavar and Sorafenib in people with Fasting, run by Yabao Pharmaceutical Group at 1 site in Canada.
Trial summary
Randomized, open-label, 3-way reference replicated crossover bioequivalence study of sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Nexavar and Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Oct 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-childbearing potential female, which includes post-menopausal female (absence of menses for 12 months prior to drug administration, bilateral oophorectomy or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration) or surgically sterile female (hysterectomy or tubal ligation at least 6 months prior to drug administration), smoker (no more than 25 cigarettes or equivalent daily) or non-smoker, ≥18 and ≤65 years of age, with BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Qualified Investigator.
- the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- lipase within normal laboratory ranges
- Capable of consent.
Who cannot join
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen at screening.
- History of allergic reactions to sorafenib, any of the excipients or other related drugs.
- Use of any drugs known to induce or inhibit CYP3A4 metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, etc.; examples of inhibitors: HIV antivirals, clarithromycin, ciprofloxacin, gestodene, etc. within 30 days prior to the first study drug administration.
- Positive pregnancy test at screening.
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
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- Clinically significant electrocardiogram (ECG) abnormalities (QTc >450) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening.
- Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
- Use of medication other than topical products without significant systemic absorption:
- prescription medication within 14 days prior to the first dosing;
- over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
- a depot injection or an implant of any drug within 3 months prior to the first dosing.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
- Hemoglobin <128 g/L (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females) at screening.
- Breast-feeding subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-label, 3-way Reference Replicated Crossover Bioequivalence Study of Sorafenib 200 mg Tablet and Nexavar (Reference) Following a 200 mg Dose in Healthy Subjects Under Fasting Conditions
Randomized, open-label, 3-way reference replicated crossover bioequivalence study of sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects under fasting conditions.
Read the detailed description
This will be a single centre, bioequivalence, open-label, randomized, single-dose, 3-period, 3-sequence, reference replicated, crossover study. 36 healthy adult males or non-childbearing potential females, ≥18 and ≤65 years of age, smoker and/or non-smoker.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexavarDrug
Single oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing.
Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose.
SorafenibDrug
Also called sarafenib
Single oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing.
Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose.
| Study group | Role | What they receive |
|---|---|---|
| sorafenib | Experimental | Sorafenib is the test product.In period 1, period 2 and period 3, 12 of 36 Subjects were given Single oral dose (1 x 200 mg) sarofenib. Receives: Drug: Nexavar; Drug: Sorafenib |
| Nexavar | Active comparator | Nexavar is the reference product.In period 1, period 2 and period 3, 24 of 36 Subjects were given Single oral dose (1 x 200 mg) Nexavar . Receives: Drug: Nexavar; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the bioequivalence of sorafenib tablet (Test)and Nexavar(Reference), on day 4.
Compare the rate and extent of absorption of sorafenib 200 mg tablet (Test) versus Nexavar (Reference), administered as 1 x 200 mg tablet under fasting conditions. Evaluate whether has the bioequivalence between the Test and the Reference.Criteria as follows: for a primary parameter (AUC0-t, AUC0-inf, or Cmax), if
- the point estimate of the Test-to-Reference ratio must be within 80.00% 125.00%, and
- the 95% upper confidence bound for the scaled average bioequivalence criterion must be equal to or less than zero (≤0) to conclude in favor of BE for that parameter.
Measured: 96 hours
Secondary outcomes (1)
safety: number TEAEs, deaths, SAEs and other significant adverse events
Number of Treatment-Emergent Adverse Events(TEAEs). Number of deaths. Number of SAEs. Number of other significant adverse events.
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yabao Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Larouche, MD, Principal investigator, employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599337
- Sponsor's protocol ID
- 150230
- Status last verified
- Jul 2015
- First submitted
- 20 Oct 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, 3-way Reference Replicated Crossover Bioequivalence Study of Sorafenib 200 mg Tablet and Nexavar (Reference) Following a 200 mg Dose in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT02599337
- Acronym / sponsor ID
- 150230
- Conditions
- Fasting
- Keywords
- bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yabao Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Nov 2015 (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.
Randomized, open-label, 3-way reference replicated crossover bioequivalence study of sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects under fasting conditions.
Detailed description
This will be a single centre, bioequivalence, open-label, randomized, single-dose, 3-period, 3-sequence, reference replicated, crossover study. 36 healthy adult males or non-childbearing potential females, ≥18 and ≤65 years of age, smoker and/or non-smoker.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sorafenib | Experimental | Drug: Nexavar, Drug: SorafenibSorafenib is the test product.In period 1, period 2 and period 3, 12 of 36 Subjects were given Single oral dose (1 x 200 mg) sarofenib. |
| Nexavar | Active comparator | Drug: Nexavar, Drug: SorafenibNexavar is the reference product.In period 1, period 2 and period 3, 24 of 36 Subjects were given Single oral dose (1 x 200 mg) Nexavar . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-childbearing potential female, which includes post-menopausal female (absence of menses for 12 months prior to drug administration, bilateral oophorectomy or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration) or surgically sterile female (hysterectomy or tubal ligation at least 6 months prior to drug administration), smoker (no more than 25 cigarettes or equivalent daily) or non-smoker, ≥18 and ≤65 years of age, with BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Healthy as defined by:
- Capable of consent.
Key exclusion criteria (17 listed)
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen at screening.
- History of allergic reactions to sorafenib, any of the excipients or other related drugs.
- Use of any drugs known to induce or inhibit CYP3A4 metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, etc.; examples of inhibitors: HIV antivirals, clarithromycin, ciprofloxacin, gestodene, etc. within 30 days prior to the first study drug administration.
- Positive pregnancy test at screening.
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 |
|---|---|---|
| NexavarSingle oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing. Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose. | Drug | Nexavar, sorafenib |
| SorafenibAlso: sarafenibSingle oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing. Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose. | Drug | Nexavar, sorafenib |
Primary outcome
Assessment of the bioequivalence of sorafenib tablet (Test)and Nexavar(Reference), on day 4.
Time frame: 96 hours
Compare the rate and extent of absorption of sorafenib 200 mg tablet (Test) versus Nexavar (Reference), administered as 1 x 200 mg tablet under fasting conditions. Evaluate whether has the bioequivalence between the Test and the Reference.Criteria as follows: for a primary parameter (AUC0-t, AUC0-inf, or Cmax), if 1. the point estimate of the Test-to-Reference ratio must be within 80.00% 125.00%, and 2. the 95% upper confidence bound for the scaled average bioequivalence criterion must be equal to or less than zero (≤0) to conclude in favor of BE for that parameter.
1 secondary outcome
safety: number TEAEs, deaths, SAEs and other significant adverse events
Time frame: 96 hours
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 6 Nov 2015.
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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.
Richard Larouche, MD principal investigator
employee
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 Nexavar and Sorafenib in people with Fasting, run by Yabao Pharmaceutical Group at 1 site in Canada.
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 6 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 6 Nov 2015. 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 Canada. 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?
Assessment of the bioequivalence of sorafenib tablet (Test)and Nexavar(Reference), on day 4. (time frame: 96 hours). 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 6 Nov 2015.