A Phase 1 interventional study of Pomalidomide 4 MG Oral Capsule in Bioequivalence Study, sponsored by Megalabs. Not yet recruiting at 1 site in India. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Megalabs · Phase 1, Interventional, and Other
Pilot bioequivalence trial of two pomalidomide formulations consisting in 4 mg oral capsules.
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.
Megalabs is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy male literate volunteers of 18 to 45 years with 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 . Negative urine test for drugs of abuse, alcohol breath analysis. Volunteers who are willing to use acceptable methods of . Volunteers who can give written and communicate effectively.
Exclusion Criteria:
History of any major surgical procedure in the past 03 months. History of any cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
History of chronic alcoholism/ chronic smoking/ drug of abuse. Volunteers with known to Pomalidomide or any of the .
History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing Volunteer who are positive for surface antigen, anti- antibody, treponemal antibodies and (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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pomalidomide 4 MG Oral Capsule per os,1 capsule per period
Drug: Pomalidomide 4 MG Oral Capsule
Pomalidomide 4 MG Oral Capsule (Pomalyst) per os,1 capsule per period
Drug: Pomalidomide 4 MG Oral Capsule
A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period
Also known as: Pomalyst, Pomalidomide Megalabs
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.
Time frame: 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.
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%
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.
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%
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Nov 2024, 2 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pomalidomide
Megalabs