Clinical trials: Bioequivalence Study, open to volunteers
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
Bioequivalence
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.
- Trial name
- NCT06830954
- Testing
- Group A, Reference Group
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
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
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
Peripheral Arterial Disease
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
To evaluate the bioequivalence and safety of AJU-B718 and B718R in Healthy Adults.
- Trial name
- NCT07901088
- Testing
- Test Drug, Reference Drug
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AJU Pharm Co., Ltd.
Healthy, Healthy Donors
Bioequivalence Study of Clonazepam 2 Mg Tablets
Demonstrate the bioequivalence in 1 study, in fasting condition of two formulations of clonazepam 2 mg Tablets / tablets immediate release in order to establish that there are no significant pharmacokinetic differences.
- Trial name
- Clonazepam (NCT06834503)
- Testing
- Rivotril®, Clonazepam TQ 2 mg
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
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
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
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
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.
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, Healthy Donors
Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions
Two bioequivalence studies of Pentoxifylline will be carried out in 40 healthy subjects, the first in a fasting condition 40 healthy subjects, the first in fasting condition and the second in postprandial condition.
- Trial name
- Pentoxifylline (NCT06823362)
- Testing
- Pentoxifylline
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Cancer, Ovarian Cancer
Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade…
- Trial name
- NCT07371104
- Testing
- DWZ2501 (Olaparib 150mg), DWC202510 (Olaparib 150mg)
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
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
Healthy Volunteer
Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets
This is an open-label, randomized, two-treatment, two-period crossover study evaluating the bioequivalence of liquid metformin formulations at 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy…
- Trial name
- NCT07300033
- Testing
- Liquid Metformin 100 mg/mL, Liquid Metformin 250 mg/mL, Metformin Immediate-Release Tablet
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Aspargo Labs, Inc
Healthy Participants
A Phase 1 Study of Navlimetostat Tablet Formulations
This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female
- Trial name
- NCT07544628
- Testing
- Navlimetostat
- Where
- 4 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers Under Fed Condition.
This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fed conditions.
- Trial name
- NCT07267221
- Testing
- DWJ1622, DWC202313, DWC202314
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Iron Deficiency Anemia
A Study of Ferric Derisomaltose Injection in Chinese Participants With Iron Deficiency Anemia Under Fasting Conditions
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in participants with iron deficiency anemia under fasting condition.
- Trial name
- NCT07790562
- Testing
- Ferric Derisomaltose Injection, Ferric Derisomaltose Injection [MonoFer®]
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Primary Hypercholesterolaemia
A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.
- Trial name
- NCT06884098
- Testing
- AD-228B, AD-2284
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.