Clinical trial NCT06058689: A Pilot Bioequivalence Study of Pomalidomide
Official title: A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Indian Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Bioequivalence Study
Lead sponsor: Megalabs
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover, bioequivalence study.
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Cmax
timeFrame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
measure: AUC0-t
timeFrame: 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%
measure: AUC0-inf
timeFrame: 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%
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Azidus Laboratories
state: Tamil Nadu
Study officials:
affiliation: Azidus Laboratories
name: M. Gowtham, MD
role: PRINCIPAL_INVESTIGATOR
References: