BioequivalencePhase 1NCT03424928
A Pilot Bioequivalence Study of Pomalidomide
A Phase 1 study testing Pomalidomide 4 MG Oral Capsule and Pomalidomide 4 MG Oral Capsule-Pomalyst in people with Bioequivalence, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Pomalidomide 4 MG Oral Capsule and Pomalidomide 4 MG Oral Capsule-Pomalyst
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2018to 6 Feb 2018
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects should read, sign and date an Informed Consent Form and be fully informed of possible adverse events prior to any study procedures.
- Subjects should complete the trial according to the regulations.
- Subjects must agree to take effective contraceptive methods to prevent pregnancy from 2 weeks before screening until 3 months of last dose administration. Subjects must agree to avoid semen and blood donation until 3 months of last dose administration.
- Healthy male volunteers of 18-50 years old.
- Body mass index (BMI) ranges from 18.0 to 28.0 kg/m2, body weight ≥ 50 kg.
- Medically healthy subjects with clinically normal Neutrophils and Platelets within 14 days.
- No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities.
Who cannot join
- Smokers (>3 cigarettes/day)
- History of allergic reactions to pomalidomide or Thalidomide analogues. Any food allergies, which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
- Any history of thrombus or liver, kidney diseases.
- History of Alcohol abuse (3990 ml beer, 1400 ml wine, 350 ml spirits/week)
- Recent donation of plasma or significant loss of whole blood (>400 ml) within 3 months.
- Subjects have difficulty to swallow or any clinical significant history of ongoing gastrointestinal problems which affect absorption of drugs.
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- Received a prescription medicine within 2 weeks prior to study dosing.
- Received a non-prescription drugs, traditional Chinese medicine, health products within prior to study dosing.
- Received a special food (dragon fruit, grapefruit or other tropical fruit) or strenuous exercise within 1 week prior to study dosing. Regular use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study administration.
- Any anticipation in other trial within 3 months.
- Abnormal laboratory tests judged clinically significant.
- Positive test result for HBsAg, HBeAg, HBeAb, HBcAB, HCvAB, HIV antibody, Syphilis screening antibody.
- Received a caffeine/Xanthine beverages or food within 48 h prior to study dosing.
- Received an alcohol within 24 h prior to study dosing or positive test result for alcohol screening.
- Positive test result for drugs of abuse.
- Other reasons which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The second hospital of shanxi medical university
Taiyuan, Shanxi, 030001
About this study
Official title: A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Chinese Healthy Volunteers.
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
- Conditions
- Bioequivalence
- Being tested
- Pomalidomide 4 MG Oral Capsule, Pomalidomide 4 MG Oral Capsule-Pomalyst
- Keywords
- Pomalidomide, Multiple myeloma, Bioequivalence
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomalidomide 4 MG Oral CapsuleDrug
per os,capsule,4mg,1 capsule per period
Pomalidomide 4 MG Oral Capsule-PomalystDrug
per os,capsule,4mg,1 capsule per period
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide 4 MG Oral Capsule | Experimental | per os,capsule,4mg,1 capsule per period Receives: Drug: Pomalidomide 4 MG Oral Capsule |
| Pomalidomide 4 MG Oral Capsule-Pomalyst | Experimental | per os,capsule,4mg,1 capsule per period Receives: Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
90% CI of T/R within 80-125%
Measured: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t)
90% CI of T/R within 80-125%
Measured: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
Area under the plasma concentration versus time curve from 0 to infinity (AUC0-inf)
90% CI of T/R within 80-125%
Measured: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start19 Jan 2018
- Primary completion29 Jan 2018
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two-way crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Hospital of Shanxi Medical University
- Responsible party
- Sponsor
- Investigators
- Ruigang Hou, Bachelor, Principal investigator, Second Hospital of Shanxi Medical UniversityLinhua Linhua, PhD, Principal investigator, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424928
- Sponsor's protocol ID
- XS-2017-001-SXYK
- Status last verified
- Feb 2018
- First submitted
- 14 Dec 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Chinese Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03424928
- Acronym / sponsor ID
- XS-2017-001-SXYK
- Conditions
- Bioequivalence
- Keywords
- Pomalidomide, Multiple myeloma, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Second Hospital of Shanxi Medical University
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 7 Feb 2018 (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.
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-way crossover
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide 4 MG Oral Capsule | Experimental | Drug: Pomalidomide 4 MG Oral Capsuleper os,capsule,4mg,1 capsule per period |
| Pomalidomide 4 MG Oral Capsule-Pomalyst | Experimental | Drug: Pomalidomide 4 MG Oral Capsule-Pomalystper os,capsule,4mg,1 capsule per period |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects should read, sign and date an Informed Consent Form and be fully informed of possible adverse events prior to any study procedures.
- Subjects should complete the trial according to the regulations.
- Subjects must agree to take effective contraceptive methods to prevent pregnancy from 2 weeks before screening until 3 months of last dose administration. Subjects must agree to avoid semen and blood donation until 3 months of last dose administration.
- Healthy male volunteers of 18-50 years old.
- Body mass index (BMI) ranges from 18.0 to 28.0 kg/m2, body weight ≥ 50 kg.
Key exclusion criteria (16 listed)
- Smokers (>3 cigarettes/day)
- History of allergic reactions to pomalidomide or Thalidomide analogues. Any food allergies, which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
- Any history of thrombus or liver, kidney diseases.
- History of Alcohol abuse (3990 ml beer, 1400 ml wine, 350 ml spirits/week)
- Recent donation of plasma or significant loss of whole blood (>400 ml) 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 |
|---|---|---|
| Pomalidomide 4 MG Oral Capsuleper os,capsule,4mg,1 capsule per period | Drug | Pomalidomide 4 MG Oral Capsule |
| Pomalidomide 4 MG Oral Capsule-Pomalystper os,capsule,4mg,1 capsule per period | Drug | Pomalidomide 4 MG Oral Capsule-Pomalyst |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
90% CI of T/R within 80-125%
Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t)
Time frame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
90% CI of T/R within 80-125%
Area under the plasma concentration versus time curve from 0 to infinity (AUC0-inf)
Time frame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
90% CI of T/R within 80-125%
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 7 Feb 2018.
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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.
Ruigang Hou, Bachelor principal investigator
Second Hospital of Shanxi Medical University
Linhua Linhua, PhD principal investigator
Second Hospital of Shanxi Medical University
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 Pomalidomide 4 MG Oral Capsule and Pomalidomide 4 MG Oral Capsule-Pomalyst in people with Bioequivalence, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
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 7 inclusion and 16 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 7 Feb 2018. 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 China. 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?
Peak Plasma Concentration (Cmax) (time frame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.). 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 7 Feb 2018.