Clinical trials: Bioequivalence
Healthy Subjects
A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects
The primary objective of this study is to demonstrate that macitentan and tadalafil administered as a fixed combination is bioequivalent to both compounds given as separate tablets given at the same doses as in the fixed…
- Trial name
- NCT03215966
- Testing
- Macitentan / tadalafil FDC, Macitentan (Opsumit®), Tadalafil (Adcirca®)
- Where
- Germany
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Actelion
Diabetes, Healthy
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.
- Trial name
- NCT01527656
- Testing
- biphasic insulin aspart 70
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy Participants
A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults
This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in…
- Trial name
- NCT06723756
- Testing
- Treatment A: BGF MDI HFO, Treatment B: BGF MDI HFA
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pharmacokinetic Study
Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each period.
- Trial name
- NCT01714856
- Testing
- Ropinirole hydrochloride CR 2mg Tablets
- Where
- India
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lupin Ltd.
Infertility, Female
A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women
MENOPUR is a human menotrophin product, with a combination of human follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.
- Trial name
- NCT04902131
- Testing
- A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL, A MENOPUR powder including solvent for solution for injection, 75 IU
- Where
- 2 sites in China
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals
Healthy
Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
- Trial name
- NCT04486157
- Testing
- IN-A012, Akynzeo 300Mg-0.5Mg Capsule
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Bioequivalence
Bioavailability of Dienogest 2.0 mg With Regards to Reference Product
This Pivotal study will investigate the bioavailability in women of 1 tablet formulations containing Dienogest 2.0 mg. The Pivotal study will be performed at a single site with 30 subjects.
- Trial name
- NCT04230083
- Testing
- Dienogest 2.0 mg Test Drug, Dienogest 2.0 mg Reference Product
- Where
- Chile
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
Helminthiasis
Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population
The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet formulations manufactured under the different granulation processes in healthy Chinese adult males.
- Trial name
- NCT01755637
- Testing
- Albendazole
- Where
- 2 sites in China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Fed
Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01578265
- Testing
- Ondansetron Tablets USP 8 mg, Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Acute Myeloid Leukemia
Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
A Randomized, Double-blind, Multiple-Dose, Two-Cycle, Parallel-Group, Bioequivalence pretrial of Daunorubicin Cytarabine liposome for Injection in older, naive patients with Acute Myeloid Leukemia (AML).
- Trial name
- NCT04920500
- Testing
- Daunorubicin Cytarabine liposome for injection, Vyxeos、Daunorubicin Cytarabine liposome for injection
- Where
- China
- Volunteers
- 16 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Healthy
Bioequivalence Study of Vildagliptin From Gliptus 50 mg Tablet (EVA Pharma, Egypt) and Galvus 50 mg Tablet (NOVARTIS PHARMA, GERMANY)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Vildagliptin from Gliptus 50 mg tablet (EVA pharma, Egypt) and Galvus 50 mg tablet (NOVARTIS PHARMA, GERMANY) in…
- Trial name
- NCT02816970
- Testing
- Vildagliptin
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Therapeutic Equivalency
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.
- Trial name
- NCT01405131
- Testing
- methylprednisolone
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Bioequivalence Study of Levetiracetam Versus Keppra
The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.
- Trial name
- NCT00926302
- Testing
- Levetiracetam (Lotus Pharmaceutical Co.,Ltd.), Keppra (Levetiracetam - USB SA Pharma Sector)
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Tri-Service General Hospital (TSGH)
Healthy
A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fasting Conditions
The purpose of this study to compare the rate and extent of absorption of Actavis Group hf, Iceland, finasteride and Merck \& Co. Inc., U.S.A. (Proscar), finasteride, administered as a 1 x 5 mg tablet, under fasting conditions.
- Trial name
- NCT00870480
- Testing
- Finasteride 5 mg Tablet, single dose, Proscar® 5 mg Tablet, single dose
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Bioequivalence Study in Healthy Subjects
Bioequivalence Assessment Between Two Imeglimin Hydrochloride Film Coated Tablet Formulations
An open label, randomized, single-dose, two-sequence, two-period, crossover study to assess the bioequivalence of Imeglimin HCl in Glimcoza 500 mg film coated tablet (Test product) in comparison with Twymeeg® 500 mg tablet…
- Trial name
- BEGliTabATCO (NCT07127094)
- Testing
- Test Product (Glimcoza), Reference (R) Twymeeg®
- Where
- Egypt
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Aya Mohammed Abdel Magid Abdel Hamid
Anthelmintic Agent
Bioequivalence Study to Compare Two Tablets of Ivermectin Tablets (3 mg Ivermectin) Versus Two Tablets of Stromectol ® Tablets (3 mg Ivermectin), in Healthy Subjects Under Fasting Conditions
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare two tablets of Ivermectin tablets (3 mg Ivermectin) versus two tablets of Stromectol ® tablets (3 mg Ivermectin), in…
- Trial name
- NCT05082753
- Testing
- Ivermectin tablets (3 mg Ivermectin), Stromectol ® tablets
- Where
- Jordan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Human Immunodeficiency Virus (HIV) Infection
Bioequivalence Study of ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions
This clinical trial aims to evaluate the bioequivalence of a single oral dose of the test drug ADC118 tablets compared with the reference drugs (ACC017 tablets and emtricitabine/tenofovir alafenamide fumarate tablets [II]) under…
- Trial name
- NCT07753902
- Testing
- ACC118-Test, Reference
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Myelodysplastic Syndrome, Myelofibrosis
Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza
The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold…
- Conditions
- Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT01290302
- Testing
- Luitpold Azacitidine, Vidaza®
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- American Regent, Inc.
Healthy
A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants
The study will aim to evaluate the following: Whether there are any differences in the way the body handles LY2963016 U-200 and LY2963016 U-100. How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.
- Trial name
- NCT02955953
- Testing
- LY2963016
- Where
- Singapore
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Bioequivalence of Roxithromycin Tablets From Two Different Manufacturers
Bioequivalence Study of Two Roxithromycin Tablets in Healthy Subjects
Roxithromycin is used for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes, sinusitis, otitis media, acute bronchitis, acute exacerbations of chronic bronchitis, and pneumonia caused by Mycoplasma…
- Trial name
- NCT06798051
- Testing
- Roxithromycin tablets 150mg
- Where
- China
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital Of Guizhou Medical University