A Pilot Bioequivalence Study of Pomalidomide

NCT03424928 | Completed Phase 1

• 1 other identifier: XS-2017-001-SXYK
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioequivalence

Keywords

Pomalidomide; Multiple myeloma; Bioequivalence

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  90% CI of T/R within 80-125%

  Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.

• Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t)

  90% CI of T/R within 80-125%

  Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.

• Area under the plasma concentration versus time curve from 0 to infinity (AUC0-inf)

  90% CI of T/R within 80-125%

  Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.

Study Arms (2)

Pomalidomide 4 MG Oral Capsule

EXPERIMENTAL

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

Drug: Pomalidomide 4 MG Oral Capsule

Pomalidomide 4 MG Oral Capsule-Pomalyst

EXPERIMENTAL

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

Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst

Interventions

Pomalidomide 4 MG Oral Capsule DRUG

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

Pomalidomide 4 MG Oral Capsule

Pomalidomide 4 MG Oral Capsule-Pomalyst DRUG

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

Pomalidomide 4 MG Oral Capsule-Pomalyst

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead
• Second Hospital of Shanxi Medical University: collaborator

Study Sites (1)

The second hospital of shanxi medical university

Taiyuan, Shanxi, 030001, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ruigang Hou, Bachelor

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Linhua Linhua, PhD

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two-way crossover

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: February 7, 2018
• Study Start: January 19, 2018
• Primary Completion: January 29, 2018
• Study Completion: February 6, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

CN (1)