Clinical trials: Bioequivalence, open to volunteers
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.
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
Metastatic Adenocarcinoma of the Pancreas
A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1
The purpose of this clinical study is to compare and evaluate the pharmacokinetic characteristics and the safety between administration of BR2021 and BR2021-1 in patients with metastatic adenocarcinoma of the pancreas
- Trial name
- NCT06867497
- Testing
- BR2021, BR2021-1
- Where
- 2 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Benign Prostatic Hyperplasia
A Clinical Trial to Evaluate the Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers
The study compare and evaluate the bioequivalence between the administration of AD-116A and the administration of AD-1161 in healthy adult male volunteers
- Trial name
- NCT07715305
- Testing
- AD-116A, AD-1161
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Overweight or Obesity
A Study of HS-20094 in Overweight or Obese Participants
This is a multicenter, randomized, open-label, parallel clinical study to evaluate the bioequivalence of the HS-20094 MDV pen and AI pen in overweight or obese subjects.
- Trial name
- NCT07057674
- Testing
- HS-20094 AI pen;, HS-20094 MDV pen
- Where
- China
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
T2D
Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.
- Trial name
- NCT07670897
- Testing
- GZR4 injection A, GZR4 injection B
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
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
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
Obesity, Overweight
A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity.
- Trial name
- NCT07597018
- Testing
- Cagrilintide D
- Where
- Germany
- Volunteers
- 234 people
- Sponsor
- Novo Nordisk A/S
Breast Cancer
Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer
This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects.
- Trial name
- NCT06765590
- Testing
- T, 260 mg/m2, paclitaxel for injection (albumin-bound), R, 260 mg/m2, paclitaxel for injection (albumin bound).
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
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.
Pediatric Growth Hormone Deficiency (PGHD)
A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
- Trial name
- NCT06840691
- Testing
- PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (T)
- Where
- China
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Glaucoma, Open-Angle, Ocular Hypertension
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.
This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle…
- Trial name
- NCT05401357
- Testing
- Test - Bimatoprost 0.01% Ophthalmic Solution, Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
- Where
- 9 sites in United States
- Volunteers
- 168 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Moderate-to-severe Benign Prostatic Hyperplasia (BPH)
Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fed Conditions
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
- Trial name
- NCT07643233
- Testing
- Test Drug, Reference Drug
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AJU Pharm Co., Ltd.
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 Volunteer Male Subjects
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting 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
- NCT07156916
- Testing
- Tamsulosin (0.4 mg/j)
- Where
- Armenia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Healthy Adult Male and Female Volunteers
A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:
The purpose of this study is to evaluate the bioavailability, safety and tolerability of Torasemide 10 mg tablets (Berlin-Chemie AG), compared to Unat® 10 tablets (Viatris Healthcare GmbH) in healthy adult participants under…
- Trial name
- NCT07201584
- Testing
- Torasemide tablet 10 mg, Unat® 10 tablets (Torasemide 10 mg)
- Where
- Kazakhstan
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics and Safety of IN-M00007 and IN-R00007 in Healthy Adult Volunteers
This study aims to evaluate the Pharmacokinetic (PK) characteristics and safety after a single oral dose administration of IN-M00007 and IN-R00007 in healthy adult volunteers
- Trial name
- NCT07311811
- Testing
- IN-R00007, IN-M00007
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
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
Basic Science
Evaluation of the Bioequivalence of RAY1225 Injection in Healthy Participants
This is a single-center, randomized, open, parallel-designed bioequivalence study aimed at evaluating the pharmacokinetic differences of RAY1225 injection after site and batch changes compared to before the changes.
- Trial name
- NCT07827027
- Testing
- RAY1225
- Volunteers
- 68 people
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd