Bioequivalence StudyPhase 1NCT06058689
A Pilot Bioequivalence Study of Pomalidomide
A Phase 1 study testing Pomalidomide 4 MG Oral Capsule in people with Bioequivalence Study, run by Megalabs at 1 site in India.
Trial summary
Pilot bioequivalence trial of two pomalidomide formulations consisting in 4 mg oral capsules. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study
- What is being tested?
- Pomalidomide 4 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2024to 15 Mar 2025
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male literate volunteers of 18 to 45 years with BMI of 18.50 - 29.99 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, alcohol breath analysis. Volunteers who are willing to use acceptable methods of contraception. Volunteers who can give 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 Pomalidomide 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.
- Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Pomalidomide 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 Volunteers who are dysphagic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Indian Healthy Volunteers
Pilot bioequivalence trial of two pomalidomide formulations consisting in 4 mg oral capsules.
Read the detailed description
An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover assignment, bioequivalence study of Pomalidomide 4 mg Capsules of Mega Labs S.A and Pomalyst® (Pomalidomide) 4 mg capsules of Celgene International SARL, Boudry, Switzerland in healthy, adult, human male subjects under fasting condition.
- Conditions
- Bioequivalence Study
- Being tested
- Pomalidomide 4 MG Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomalidomide 4 MG Oral CapsuleDrug
Also called Pomalyst, Pomalidomide Megalabs
A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide Test | Experimental | Pomalidomide 4 MG Oral Capsule per os,1 capsule per period Receives: Drug: Pomalidomide 4 MG Oral Capsule |
| Pomalidomide Reference | Experimental | Pomalidomide 4 MG Oral Capsule (Pomalyst) per os,1 capsule per period Receives: Drug: Pomalidomide 4 MG Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak Plasma Concentration (Cmax). T/R of Cmax R within 80-125% for IC 90% vs the Comparator; also to generate pharmacokinetic data that can be used to design a pivotal bioequivalence study.
Measured: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
AUC0-t
Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t). T/R of AUC 0-t within 80-125% for 90% CI vs the Comparator.
Measured: 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%
AUC0-inf
Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t). T/R of AUC 0-t within 80-125% for 90% CI vs the Comparator.
Measured: 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%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Sep 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence StudyStudies 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
- Model description
- An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover, bioequivalence study.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
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
- NCT06058689
- Sponsor's protocol ID
- Pomalidomide
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Sep 2023. 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 Indian Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06058689
- Acronym / sponsor ID
- Pomalidomide
- Conditions
- Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- MegalabsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 28 Sep 2023 (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.
Pilot bioequivalence trial of two pomalidomide formulations consisting in 4 mg oral capsules.
Detailed description
An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover assignment, bioequivalence study of Pomalidomide 4 mg Capsules of Mega Labs S.A and Pomalyst® (Pomalidomide) 4 mg capsules of Celgene International SARL, Boudry, Switzerland in healthy, adult, human male subjects under fasting condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover, bioequivalence study.
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide Test | Experimental | Drug: Pomalidomide 4 MG Oral CapsulePomalidomide 4 MG Oral Capsule per os,1 capsule per period |
| Pomalidomide Reference | Experimental | Drug: Pomalidomide 4 MG Oral CapsulePomalidomide 4 MG Oral Capsule (Pomalyst) per os,1 capsule per period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male literate volunteers of 18 to 45 years with BMI of 18.50 - 29.99 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, alcohol breath analysis. Volunteers who are willing to use acceptable methods of contraception. Volunteers who can give written informed consent and communicate effectively.
Key exclusion criteria (7 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 Pomalidomide 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.
- Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Pomalidomide 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.
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 CapsuleAlso: Pomalyst, Pomalidomide MegalabsA single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period | Drug | Pomalidomide Reference, Pomalidomide Test |
Primary outcome
Cmax
Time frame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
Peak Plasma Concentration (Cmax). T/R of Cmax R within 80-125% for IC 90% vs the Comparator; also to generate pharmacokinetic data that can be used to design a pivotal bioequivalence study.
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 the last measurable concentration (AUC0-t). T/R of AUC 0-t within 80-125% for 90% CI vs the Comparator.
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%
Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t). T/R of AUC 0-t within 80-125% for 90% CI vs the Comparator.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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 1 study testing Pomalidomide 4 MG Oral Capsule in people with Bioequivalence Study, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcos Giusti, MD (+ (598) 2683 8000, mgiusti@megalabs.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 28 Sep 2023.