A Pilot Bioequivalence Study of Pomalidomide

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03424928

Collaborator

Second Hospital of Shanxi Medical University (Other)

Enrollment

Location

Arms

Actual Duration (Days)

20.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bioequivalence	Drug: Pomalidomide 4 MG Oral Capsule Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

two-way crossovertwo-way crossover

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Chinese Healthy Volunteers.

Actual Study Start Date :

Jan 19, 2018

Actual Primary Completion Date :

Jan 29, 2018

Actual Study Completion Date :

Feb 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pomalidomide 4 MG Oral Capsule per os,capsule,4mg,1 capsule per period	Drug: Pomalidomide 4 MG Oral Capsule per os,capsule,4mg,1 capsule per period
Experimental: Pomalidomide 4 MG Oral Capsule-Pomalyst per os,capsule,4mg,1 capsule per period	Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst per os,capsule,4mg,1 capsule per period

Arm

Intervention/Treatment

Experimental: Pomalidomide 4 MG Oral Capsule

per os,capsule,4mg,1 capsule per period

Drug: Pomalidomide 4 MG Oral Capsule

per os,capsule,4mg,1 capsule per period

Experimental: Pomalidomide 4 MG Oral Capsule-Pomalyst

per os,capsule,4mg,1 capsule per period

Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst

per os,capsule,4mg,1 capsule per period

Outcome Measures

Primary Outcome Measures

Peak Plasma Concentration (Cmax) [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) [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) [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%

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second hospital of shanxi medical university	Taiyuan	Shanxi	China	030001

Sponsors and Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.
Second Hospital of Shanxi Medical University

Investigators

Principal Investigator: Ruigang Hou, Bachelor, Second Hospital of Shanxi Medical University
Principal Investigator: Linhua Linhua, PhD, Second Hospital of Shanxi Medical University