Clinical trials: Therapeutic Equivalency
Healthy
Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fed Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of Risperidone formulations after administration of single doses to normal, healthy subjects under fed conditions.
- Trial name
- NCT01222923
- Testing
- Risperidone
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study to Compare Two Formulations of LY3209590 in Healthy Participants
The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits.
- Trial name
- NCT05914688
- Testing
- LY3209590 (Formulation 1), LY3209590 (Formulation 2)
- Where
- Singapore
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study comparing a single oral dose of fenofibrate capsules, USP 130 mg, of Ohm Laboratories Inc.
- Trial name
- NCT02306889
- Testing
- Fenofibrate, ANTARA® (fenofibrate)
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Fasting
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fed Condition
The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fed condition.
- Trial name
- NCT01831674
- Testing
- Metformin Hydrochloride Extended-Release Tablets USP 750, GLUCOPHAGE®XR tablet 750 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.
- Trial name
- NCT06393127
- Testing
- Nerandomilast
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bilateral Cataract
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye.
- Trial name
- TBO (NCT02734459)
- Testing
- cataract surgery
- Volunteers
- 756 people
- Sponsor
- Semler Research Center Pvt. Ltd.
Healthy Volunteers
Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects
To investigate and compare the drug amount delivered to the body after each single administration of Rotigotine patch with 2 different formulations in healthy Japanese subjects.
- Trial name
- NCT01565018
- Testing
- Rotigotine PR 2.1.4, Rotigotine PR 2.2.1
- Where
- Germany
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Primary Ovarian Insufficiency, Vaginitis
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
- Conditions
- Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause
- Trial name
- NCT01436513
- Testing
- Premarin reference tablet (fasted), Premarin new tablet (fasted), Premarin reference tablet (fed)
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bioequivalence
Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta
Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy…
- Trial name
- NCT03146988
- Testing
- RGB-02 or Neulasta® (pegfilgrastim)
- Where
- United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Gedeon Richter Plc.
Healthy
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA with that of 3 mg XANAX XR® Tablets by…
- Trial name
- NCT00829426
- Testing
- Alprazolam Extended-Release 3 mg Tablets
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions
The objective of this study was to compare the relative bioavailability of Lansoprazole DR Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human subjects.
- Trial name
- NCT01270308
- Testing
- Lansoprazole
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Anti-Infective Agents
Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods.
- Trial name
- NCT01105208
- Testing
- Cephalexin suspension (Optocef, BAYO5448 ), Cephalexin suspension (Keflex)
- Where
- Mexico
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fasting Conditions
The purpose of this study is to evaluate and compare the relative bioavailability, and therefore the bioequivalence of two formulations of Citalopram after a single dose administration under fasting conditions.
- Trial name
- NCT00865085
- Testing
- Citalopram HBr 40 mg tablets, single dose, CelexaTM 40 mg tablets, single dose
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233097
- Testing
- Esomeprazole magnesium dihydrate-Test product, Esomeprazole magnesium dihydrate-Reference product
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions
The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fasting conditions.
- Trial name
- NCT00778778
- Testing
- cefprozil 500mg tablets
- Where
- Canada
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bioequivalence
Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions
This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test…
- Trial name
- NCT04753489
- Testing
- Rivaroxaban film-coated tablet 10 mg, Xarelto® film-coated tablet 10 mg
- Where
- Russia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers
This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.
- Trial name
- NCT05954338
- Testing
- DWC202307, DWJ1543, DWC202216
- Volunteers
- 52 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Actinic Keratosis (AK)
Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream
To compare the relative efficacy and safety and of 5-FU Cream to the marketed formulation Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in…
- Trial name
- NCT03727074
- Testing
- 5-FU Cream, Efudex®, Vehicle
- Where
- United States
- Volunteers
- 462 people
- Sponsor
- Sol-Gel Technologies, Ltd.
Solid Tumor
A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
This is a multicenter, open-label, 2-stage study with a 2-treatment period crossover design. Eligible participants are adults with cancer for whom weekly therapy with IV paclitaxel at a dose of 80 mg/m2 over 1 hour is indicated.
- Trial name
- NCT04035473
- Testing
- HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules
- Where
- 7 sites in Australia, New Zealand and 1 more
- Volunteers
- 42 people
- Sponsor
- Athenex, Inc.
Depressive Disorder
PAXIL CR Bioequivalence Study
This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
- Trial name
- NCT00749359
- Testing
- Paxil CR
- Where
- 2 sites in United States
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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