BioequivalencePhase 4NCT06331715
Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg
A Phase 4 study testing Palbociclib 125mg in people with Bioequivalence, run by Megalabs at 1 site in India.
Trial summary
An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Palbociclib 125mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 6 Feb 2024to 31 May 2024
- Phase
- Phase 4
- 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/or non-pregnant, non-breast feeding female literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 30.00 Kg/m2 and weight > 50 Kg.
- Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
- Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
- Normal or clinically insignificant ECG.
- Negative urine test for drugs of abuse and alcohol breath analysis for both males and females,
- Negative pregnancy test for females and do not plan to become pregnant during course of the study and for 03 months after completion of study.
- Volunteers who are willing to use acceptable methods of contraception during course of the study and for 03 months after completion of study.
- Volunteers who can give voluntary written informed consent and communicate effectively.
Who cannot join
- History of any major surgical procedure in the past 03 months.
- History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
- History of chronic alcoholism/ chronic smoking/ drug of abuse.
- Volunteers with known hypersensitivity to Palbociclib or any of the excipients.
- History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
- Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
Show all 12Show fewer
- Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs/ vaccines (including COVID 19 vaccines) within 14 days which potentially modify kinetics / dynamics of Palbociclib or any other medication judged to be clinically significant by the investigator.
- History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
- Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.
- History of consumption of one or more of the below, 48 hours prior to dosing:
- Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator
- History of difficulties in swallowing tablets/capsules.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Two Periods, Single Dose, Crossover Bioequivalence Study of Palbociclib 125 mg Capsules (Iclos) and Ibrance (Palbociclib) 125 mg Capsules Pfizer in Healthy Subjects Under Fed Condition
An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition.
Read the detailed description
24 healthy subjects males and/or non pregnant, non breast feeding females will be randomized to receive either Test product (Palbociclib 125 mg Capsules of Iclos Uruguay S.A.) or Reference product (Ibrance® Palbociclib 125 mg Capsules of Pfizer Europe in healthy, adult, human subjects under fed condition. Trial design will be balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of in healthy, adult, human subjects under fed condition to assess the bioequivalence between test and comparator formulations.
Statistical analysis will be performed on the Ln-transformed pharmacokinetic parameters using SAS® v 9.4. The analysis will include data from subjects who complete the study. If there are dropouts, no replacement will be done.
To establish bioequivalence of the test product with that of comparator product, 90% Confidence Interval (CI) for the ratio (Test/ Comparator) of Least Square Means of the log transformed PK parameters (Cmax and AUC0-72) must fall between 80.00% and 125.00%. Confidence Interval (CI) values will not be rounded off.
- Conditions
- Bioequivalence
- Being tested
- Palbociclib 125mg
- Keywords
- palbociclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib 125mgDrug
Also called Ibrance, Palbociclib Iclos
Pharmacokinetic parameters AUC and Cmax will be evaluated to establish bioequivalence betweeen the Test and Reference products
| Study group | Role | What they receive |
|---|---|---|
| TR | Experimental | Subject will receive Test product palbociclib (125 mg Iclos) followed by reference product (Ibrance Pfizer 125 mg capsules) after 14 days washout Receives: Drug: Palbociclib 125mg |
| RT | Experimental | Subject will receive reference product (Ibrance Pfizer 125 mg capsules) followed by Test product palbociclib (125 mg Iclos) after 14 days washout Receives: Drug: Palbociclib 125mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-t
Least Square Means of Test/Reference Ratio of Area Under Plasma concentration vs. time between 80-125 for 90%IC
Measured: 72 hours
Cmax
Least Square Means of Test/Reference Ratio of maximum plasma concentration between 80-125 for 90%IC
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start6 Feb 2024
- Primary completion1 Apr 2024
- Study completion31 May 2024
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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Megalabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M Gowtham, MD, Principal investigator, Azidus Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331715
- Sponsor's protocol ID
- ML1005
- Status last verified
- Aug 2024
- First submitted
- 19 Mar 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Two Periods, Single Dose, Crossover Bioequivalence Study of Palbociclib 125 mg Capsules (Iclos) and Ibrance (Palbociclib) 125 mg Capsules Pfizer in Healthy Subjects Under Fed Condition
- ClinicalTrials.gov ID
- NCT06331715
- Acronym / sponsor ID
- ML1005
- Conditions
- Bioequivalence
- Keywords
- palbociclib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- MegalabsIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 26 Mar 2024 (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.
An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition.
Detailed description
24 healthy subjects males and/or non pregnant, non breast feeding females will be randomized to receive either Test product (Palbociclib 125 mg Capsules of Iclos Uruguay S.A.) or Reference product (Ibrance® Palbociclib 125 mg Capsules of Pfizer Europe in healthy, adult, human subjects under fed condition. Trial design will be balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of in healthy, adult, human subjects under fed condition to assess the bioequivalence between test and comparator formulations.
Statistical analysis will be performed on the Ln-transformed pharmacokinetic parameters using SAS® v 9.4. The analysis will include data from subjects who complete the study. If there are dropouts, no replacement will be done.
To establish bioequivalence of the test product with that of comparator product, 90% Confidence Interval (CI) for the ratio (Test/ Comparator) of Least Square Means of the log transformed PK parameters (Cmax and AUC0-72) must fall between 80.00% and 125.00%. Confidence Interval (CI) values will not be rounded off.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR | Experimental | Drug: Palbociclib 125mgSubject will receive Test product palbociclib (125 mg Iclos) followed by reference product (Ibrance Pfizer 125 mg capsules) after 14 days washout |
| RT | Experimental | Drug: Palbociclib 125mgSubject will receive reference product (Ibrance Pfizer 125 mg capsules) followed by Test product palbociclib (125 mg Iclos) after 14 days washout |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male and/or non-pregnant, non-breast feeding female literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 30.00 Kg/m2 and weight > 50 Kg.
- Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
- Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
- Normal or clinically insignificant ECG.
- Negative urine test for drugs of abuse and alcohol breath analysis for both males and females,
Key exclusion criteria (12 listed)
- History of any major surgical procedure in the past 03 months.
- History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
- History of chronic alcoholism/ chronic smoking/ drug of abuse.
- Volunteers with known hypersensitivity to Palbociclib or any of the excipients.
- History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
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 |
|---|---|---|
| Palbociclib 125mgAlso: Ibrance, Palbociclib IclosPharmacokinetic parameters AUC and Cmax will be evaluated to establish bioequivalence betweeen the Test and Reference products | Drug | RT, TR |
Primary outcome
AUC 0-t
Time frame: 72 hours
Least Square Means of Test/Reference Ratio of Area Under Plasma concentration vs. time between 80-125 for 90%IC
Cmax
Time frame: 72 hours
Least Square Means of Test/Reference Ratio of maximum plasma concentration between 80-125 for 90%IC
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 19 Aug 2024.
- FDA guidance for the bioequivalence of dasatinibLink provided by the sponsor.
- EMA bioequivalence guideline for palbociclibLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
M Gowtham, MD principal investigator
Azidus Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Palbociclib 125mg in people with Bioequivalence, run by Megalabs at 1 site in India.
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 8 inclusion and 12 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 19 Aug 2024. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 0-t (time frame: 72 hours). 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 19 Aug 2024.