Clinical trials: Therapeutic Equivalency
Healthy
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in subjects fed a high standard fat meal.
- Trial name
- NCT01161979
- Testing
- Zonisamide, Zonegran
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Therapeutic Equivalency, Food
Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial…
- Trial name
- NCT00807118
- Testing
- Fesoterodine
- Where
- Japan
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects…
- Trial name
- NCT01645410
- Testing
- Atorvastatin Calcium Tablets, 40 mg
- Where
- India
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Chronic Heart Failure
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
Primary objective is to is to evaluate the bioequivalence of two formulations
- Trial name
- NCT06266988
- Testing
- Sacubitril and Valsartan Tablets 97mg/103mg, Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Viatris Inc.
Healthy Volunteers
A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2…
- Trial name
- NCT07146750
- Testing
- SAR445229
- Where
- United States
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01888250
- Testing
- Lamotrigine
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Sumatriptan 100mg Tablets Under Fasting Conditions
An open label, bioequivalence study of sumatriptan succinate 100 mg tablets (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) under fasting Conditions
- Trial name
- NCT00872924
- Testing
- sumatriptan 100mg
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Subjects in Fasted and Fed State
The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
- Trial name
- NCT03216278
- Testing
- Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500 mg, Dapagliflozin/metformin XR 10/1000mg
- Where
- Brazil
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)
Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck…
- Trial name
- NCT05798715
- Testing
- Gleptomet 50/1000(Metformin HCl & Sitagliptin), Janumet 50/1000(Metformin HCl & Sitagliptin)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Bioequivalence
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions
The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2 mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States Pharmacopeia (USP), 2 mg (Mylan…
- Trial name
- NCT04411940
- Testing
- Haloperidol Tablets, Mylan Pharmaceuticals Inc., Haloperidol Tablets, Cycle Pharmaceuticals Ltd
- Where
- South Africa
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
COPD
Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg
- Trial name
- ARBORUS (NCT05986591)
- Testing
- Test Product - Tiotropium Bromide Inhalation Powder 18 mcg, Spiriva Handihaler (Tiotropium Bromide) 18 mcg
- Where
- 33 sites in United States, India
- Volunteers
- 335 people
- Sponsor
- Xiromed LLC
Healthy
Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg
The objective of this study was to investigate the bioequivalence of Mylan's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed…
- Trial name
- NCT00649987
- Testing
- Albuterol Sulfate Extended-Release Tablets 8 mg, VoSpire® ER Tablets 8 mg
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension
The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation.
- Trial name
- NCT01682538
- Testing
- Nitisinone, capsule, Nitisinone, suspension
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Breast Cancer
Phase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest Wall
This is a research study to evaluate the effects of ThermoDox in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer.
- Trial name
- DIGNITY (NCT00826085)
- Testing
- ThermoDox in combination with Microwave Hyperthermia (heat)
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Imunon
Pain
Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)
This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.
- Trial name
- NCT00945035
- Testing
- etoricoxib, Comparator: etoricoxib
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Healthy
Bioequivalence Study of Clopidogrel Tablets 75 mg Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75 mg tablet under fed condition.
- Trial name
- NCT01512485
- Testing
- Clopidogrel
- Where
- Canada
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Heathy Participants
Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant.
This study will investigate the Pharmacokinetic (PK) and safety of Budesonide and albuterol (BDA) metered dose inhaler (MDI) HFO and BDA MDI HFA in healthy male and female participants.
- Trial name
- NCT06139991
- Testing
- Treatment A (BDA MDI HFO), Treatment B (BDA MDI HFA)
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Subjects
Bioequivalence Study Between YHP2508C and YHR2603 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508C and YHR2603 in healthy subjects
- Trial name
- NCT07584304
- Testing
- YHP2508C, YHR2603
- Where
- South Korea
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Bioequivalence in Healthy Subjects
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Listro Mix 50/50® and Humalog Mix50/50® in Healthy Subjects
The aim of this study is to assess the bioequivalence of two premixed formulations of insulin Lispro, Humalog Mix50/50® and ListroMix 50/50® in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic…
- Trial name
- NCT01400789
- Testing
- Insulin Lispro
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy Subjects
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of…
- Trial name
- NCT04096157
- Testing
- Isavuconazonium sulfate IV, Isavuconazonium sulfate capsules
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
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