Clinical trials: Bioequivalence Study, active
Prostate Cancer (CRPC)
Study on Human Bioequivalence of Triprerelin Acetate for Injection
To investigate the pharmacokinetics of triprerelin acetate for injection and triprerelin acetate (Dufferin ®) for injection of reference preparation in patients with prostate cancer by single intramusculodynamic injection in…
- Trial name
- NCT06683066
- Testing
- Triprorelin for injection, Diphereline
- Where
- China
- Volunteers
- 120 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Bioequivalence
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…
- Trial name
- NCT07096869
- Testing
- Paclitaxel protein-bound particles for injectable suspension (albumin-bound), Abraxane®
- Where
- China
- Volunteers
- 28 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Healthy
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting…
- Trial name
- NCT07610005
- Testing
- Varegacestat Reference Formulation, Varegacestat Test Formulation A, Varegacestat Test Formulation B
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Immunome, Inc.
Healthy, Obesity
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product [formulation A]) and in a vial (test product [formulation B2]) in male and female trial participants…
- Trial name
- NCT07768813
- Testing
- Survodutide formulation A, Survodutide formulation B2
- Where
- Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.
- Trial name
- NCT07845630
- Testing
- Vicadrostat, Empagliflozin, Vicadrostat + empagliflozin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Ovarian Cancer
A Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer
This was a multicenter, open-label, randomized, crossover bioequivalence study to evaluate the pharmacokinetics and safety of BR2022 and BR2022-1 in Patients with deleterious or suspected deleterious germline BRCA-mutated…
- Trial name
- NCT07069335
- Testing
- Olaparib 150 MG
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Non-valvular Atrial Fibrillation (NVAF)
To Compare the Pharmacokinetics and Safety After a Single Dose Administration of IN-G00002 and IN-R00002 in Healthy Adult Volunteers
To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers
- Trial name
- NCT06725355
- Testing
- IN-R00002, IN-G00002
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy, Healthy Donors
Bioequivalence Study of Revolade® Eltrombopag 50 mg
Bioequivalence Study
- Trial name
- Eltrombopag (NCT06834451)
- Testing
- Revolade®, Eltrombopag (EPAG)
- Where
- Colombia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Cetuximab, Bioequivalence
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection versus Erbitux in Healthy Male Subjects
- Conditions
- Cetuximab, Bioequivalence, Healthy Volunteers, Pharmacokinetics
- Trial name
- BT-HC034S-101 (NCT07813468)
- Testing
- HC034S, Erbitux (Cetuximab)
- Where
- China
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- HC Biopharma Inc.
Healthy, Healthy Donors
Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition
- Trial name
- NCT06861842
- Testing
- Theralite®, Actilitio®
- Where
- Colombia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Chronic Graft Versus Host Disease
Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants
The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants…
- Trial name
- NCT07726914
- Testing
- Belumosudil
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteers
A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers
This study is a multicenter, randomized, double-masked, parallel-group, reference-drug-controlled clinical trial of IBI3027 in healthy male volunteers.
- Trial name
- NCT07502534
- Testing
- IBI3027, DUPIXENT® (dupilumab)
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Osteoporosis
A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects
To investigate the pharmacokinetics of the test preparation abalparatide injection and the reference preparation abalparatide injection (Tymlos®) in healthy adult subjects under fasting state, and to evaluate the bioequivalence…
- Trial name
- NCT06753864
- Testing
- Test (T), Reference (R)
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Healthy Volunteers, Male
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin 0.4 mg Tablets, in Healthy Adult Male Subjects, Under Fed Conditions
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0,4 mg…
- Trial name
- NCT07091669
- Testing
- Tamsulosin (0.4 mg/j)
- Where
- Armenia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Erectile Dysfunction
Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.
The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil…
- Trial name
- NCT06782659
- Testing
- ASP-001, Viagra
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Aspargo Labs, Inc
Healhty
Correlation Studies on Human Body Composition Based on Bioequivalence or Pharmacokinetic Trials
The aim of this observational study is to investigate the impact of body composition on the absorption, distribution, and metabolism of drugs.
- Trial name
- NCT07611929
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Drug Effect, Safety Issues
Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are 1.
- Conditions
- Drug Effect, Safety Issues, Immunogenicity
- Trial name
- NCT06497036
- Testing
- GP404141, Nplate
- Where
- 6 sites in Russia
- Volunteers
- 160 people
- Sponsor
- Geropharm
Schizophrenia
A Bioequivalence Study of PP3M in Patients With Schizophrenia
To evaluate the bioequivalence of the test formulation paliperidone palmitate injection (3M) produced by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Trial name
- NCT07493551
- Testing
- Paliperidone Palmitate Injection (3M)
- Where
- China
- Volunteers
- 260 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Primary Hypertension
Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets
This study aims to evaluate the bioequivalence and safety of single oral administration of Sacubitril/Valsartan/Amlodipine Tablets (240mg/5mg) versus Sacubitril/Valsartan Calcium Tablets (240mg) combined with Amlodipine Besylate…
- Trial name
- NCT07486453
- Testing
- Sequence A T-R-T-R, Sequence B R-T-R-T
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Myeloma Multiple
Bioequivalence Studies of Dasatinib 100 Mg
A bioequivalence study of Dasatinib will be carried out in 46 healthy subjects, in fed condition, following the complete replicated design, randomized, comparative of 2 sequences, 2 study formulations, in a single dose of 100 mg…
- Trial name
- BE-Dasatinib (NCT05944783)
- Testing
- Dasatinib 100 MG
- Where
- Colombia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica