Clinical trials: Bioequivalence
Healthy
Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under…
- Trial name
- NCT00649129
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Psoriasis
Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults
BFI-751 is being developed by BioFactura Australia Pty Ltd as a biosimilar drug to Stelara® (EU licenced and US licenced) (ustekinumab) is a prescription biologic medicine used to treat people with Crohn's disease, Ulcerative…
- Trial name
- NCT04843631
- Testing
- BFI-751, EU-STELARA®, US-STELARA®
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- BioFactura Australia Pty Ltd.
Healthy
Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.
- Trial name
- NCT00834977
- Testing
- Amlodipine-benazepril 10 mg-20 mg capsules, Lotrel® 10 mg-20 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food
The aim of this trial is to establish bioequivalence between EU-, US- and Japan-sourced Otezla® tablet formulations to assure comparability of results from Phase III trials of BI 730357 (new oral agent for treatment of psoriasis…
- Trial name
- NCT04811573
- Testing
- EU-sourced Otezla®, US-sourced Otezla®, Japan-sourced Otezla®
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.
- Trial name
- NCT00881894
- Testing
- Rotigotine transdermal patch
- Where
- Germany
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Healthy, Plasma Concentration of YM060
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet
A study to compare time-course changes of plasma concentration of YM060 after intake of conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be administered without water.
- Trial name
- NCT01392794
- Testing
- YM060
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy
Bioequivalence Study of 120 mg Etoricoxib Film-coated Tablets
The present study was a randomized, open-label, two-period, two-sequence, cross-over study, conducted to find out whether the etoricoxib 120 mg film-coated tablet produced by PT Dexa Medica (test drug) was bioequivalent to the…
- Trial name
- NCT03422575
- Testing
- Etoricoxib 120Mg Film-coated Tablet, Arcoxia® 120 mg Film-coated tablet (Frosst Iberica S.A., Spain for Merck Sharp & Dohme (Australia) Pty Limited, Australia, registered by PT. Schering-Plough Indonesia Tbk)
- Where
- Indonesia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Healthy
A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers
The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration.
- Trial name
- NCT06360081
- Testing
- Zongertinib manufacturer 1, Zongertinib manufacturer 2
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Alopecia
Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers
The aim of this study is to determine the bioequivalence of 5 x 0.1 milligram (mg) capsules compared to 1 x 0.5 mg capsule of dutasteride in healthy male subjects.
- Trial name
- NCT01929330
- Testing
- GI198745 0.1 mg, GI198745 0.5 mg
- Where
- Australia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers
An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects
- Trial name
- NCT06613139
- Testing
- YHP2305, YHR2404
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Healthy
Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions
The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 suspensions in healthy male volunteers.
- Trial name
- NCT02941731
- Testing
- HIP1403, HGP0919
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Healthy Volunteer
Bioequivalence Study of Generic Celecoxib 200 mg Capsules
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions
- Trial name
- NCT06337422
- Testing
- Celecoxib 200 mg capsule
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Bio service
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6…
- Trial name
- NCT04014062
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
HIV Infections
Bioequivalence Study of Didanosine in Children Treated for HIV
The purpose of this study is to show that the administration of 400/mg/m2/day of didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of didanosine during fasting, in HIV infected children…
- Trial name
- ddI (NCT00668356)
- Testing
- didanosine
- Where
- France
- Volunteers
- 26 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Healthy
Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers
To establish the bioequivalence of the new tipranavir oral solution formulation with the current tipranavir oral solution formulation following single-dose administration.
- Trial name
- NCT02244190
- Testing
- Tipranavir, Ritonavir
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Apixaban Tablets in Healthy Chinese Subjects
To evaluate the single-center, open, randomized, single-dose, two-cycle, two-sequence, cross-over bioequivalence of test preparation apixaban tablet 2.5mg and reference preparation 2.5mg in healthy adult subjects in fasting and…
- Trial name
- NCT05841446
- Testing
- test apixaban tablets, reference apixaban tablets
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Chronic Idiopathic Constipation
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
- Trial name
- NCT03097861
- Testing
- Lubiprostone
- Where
- 67 sites in United States
- Volunteers
- 552 people
- Sponsor
- Sucampo Pharma Americas, LLC
Type 2 Diabetes Mellitus(T2DM)
A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration
The primary objective of this study is to assess the pharmacokinetic parameters of saxagliptin and metformin in healthy male Chinese subjects.
- Trial name
- SAXA (NCT01755494)
- Testing
- Saxagliptin 5 mg, Metformin XR 500 mg, Mertformin XR 2 x 500 mg
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Respiratory
Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma
This is a randomized, multi-center, multiple-dose, double-blind, placebo-controlled, Parallel group design, clinical endpoint bioequivalence study in adult participants with asthma.
- Trial name
- NCT07223294
- Testing
- Fluticasone furoate and vilanterol inhalation powder, Breo Ellipta
- Sponsor
- Sandoz
Fed Conditions, Healthy Volunteer
A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal
Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers
- Trial name
- NCT07333742
- Testing
- Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LG Chem