Trials / Completed
CompletedNCT03424928
A Pilot Bioequivalence Study of Pomalidomide
A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Chinese Healthy Volunteers.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pomalidomide 4 MG Oral Capsule | per os,capsule,4mg,1 capsule per period |
| DRUG | Pomalidomide 4 MG Oral Capsule-Pomalyst | per os,capsule,4mg,1 capsule per period |
Timeline
- Start date
- 2018-01-19
- Primary completion
- 2018-01-29
- Completion
- 2018-02-06
- First posted
- 2018-02-07
- Last updated
- 2018-02-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03424928. Inclusion in this directory is not an endorsement.