Bioequivalence

3

Review clinical trials related to Bioequivalence. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients

The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer patients.

Participants needed: 28
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Updated: Jul 31, 2025Locations: 1
Eligibility criteria

1) Subjects fully understand the purpose, nature, method and possible adverse re... [+7]

1) A severe allergy or hypersensitivity to paclitaxel or human albumin; [+17]

Status: Not yet recruiting

Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants

The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd. and the reference preparation (80 mg) manufactured by Beijing Novartis Pharma Co., Ltd. in healthy participants under fasting and fed conditions.

Participants needed: 110
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.Updated: Feb 17, 2025
Eligibility criteria

Participants have fully understood the trial's objectives, procedures, and poten... [+4]

Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a... [+11]

Status: Not yet recruiting

Coffee Bioequivalence Trial

The goal of this clinical trial is to test if coffee consumed as a tablet is biologically equivalent to that consumed traditionally as a drink. It will also learn about the impact of the short-term intake of coffee on markers of cardiovascular and liver health. The main questions it aims to answer are: * Do coffee bioactive compounds produce the same levels in blood and urine regardless of how the coffee is consumed (tablet or drink)? * How does coffee as a tablet or drink impact cardiovascular risk and liver health versus a non-coffee control? Participants will: * Visit the clinical unit for three phases; each phase is 1x 480 minute (eight hour) acute postprandial visit and 1 x one hour visit the following day. During each phase they will be randomly assigned to take a different intervention (coffee drink, coffee tablet, coffee-free control) * Be cannulated during the 480 minute (8 hour) acute visits and have regular blood draws as well as basic clinical assessments * Return on day two for a fasting blood sample and basic clinical assessment * Collect their urine for 24 h * Be asked to record their intake of foods and drinks for 3 days to assess their usual diet (dietary assessment).

Participants needed: 16
Trial details
Age: 18-45Biological sex: AllType: InterventionalSponsor: University of ReadingUpdated: Jan 3, 2025Locations: 1
Eligibility criteria

Healthy males and pre-menopausal females (must have regular menstrual cycles) [+2]

Sensitivity to coffee and caffeine [+12]