Clinical trials: Therapeutic Equivalency
Healthy
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fasting…
- Trial name
- NCT01131728
- Testing
- Naproxen Sodium & Pseudoephedrine HCl
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study
The purpose of this study was to assess bioequivalence (BE) of newly developed Glucophage® XR (GXR) reduced mass (RM) tablet (metformin hydrochloride 500 milligrams (mg) test tablet) and marketed Glucophage ® XR tablet (metformin…
- Trial name
- NCT04684420
- Testing
- Glucophage® XR RM Test, Glucophage® XR Reference
- Where
- South Korea
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation
Primary objective for this study is to demonstrate bioequivalence between Japanese commercial tablet and Japanese commercial image liquid formulation.
- Trial name
- NCT00987779
- Testing
- Gabapentin
- Where
- Singapore
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions
The objective of the study was to compare the single-dose oral bioavailability of Clarithromycin 250 mg tablets of Ranbaxy Laboratories with Biaxin 250 mg tablets of Abbott Laboratories in healthy, adult, human subjects under…
- Trial name
- NCT00774189
- Testing
- clarithromycin 250 mg tablets
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen, in Healthy Subjects, Under Fasting Conditions
Bioavailability comparison study with a cross-over desing, 2x2, open, prospective and longitudinal, at a single dose with two treatments, two periods, two sequences with an elimination (washout) period of 7 days and a number of…
- Trial name
- NCT05027126
- Testing
- Dexketoprofen 25 MG, Fixed dose Dexketoprofen-Vitamin B Complex
- Where
- Mexico
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions
To compare the relative bioavailability of Kali and Ortho-McNeil's
- Trial name
- NCT00653315
- Testing
- Tramadol APAP, Ultracet
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Type 2 Diabetes Mellitus (T2DM)
Bioequivalence Study to Compare Empagliflozin/ Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet versus Synjardy XR tablets…
- Trial name
- NCT07694115
- Testing
- Empagliflozin / Metformin Extended-Release Tablet, Synjardy XR tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Headache, Tension-Type
A Pharmacokinetic Study of an Experimental Paracetamol Formulation
This PK study is designed to show bioequivalence between the study treatments.
- Trial name
- NCT01476176
- Testing
- Experimental paracetamol, Paracetamol marketed formulation
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type II Diabetes
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.
- Trial name
- NCT05108350
- Testing
- T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR, T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Rheumatoid Arthritis
MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of…
- Trial name
- NCT02468791
- Testing
- Rituximab
- Where
- 51 sites in Bosnia and Herzegovina, Georgia and 3 more
- Volunteers
- 709 people
- Sponsor
- Mabion SA
Chronic Obstructive Pulmonary Disease
Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant
The study will assess the Pharmacokinetic (PK) and safety of BGF MDI [Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)] formulated with 2 different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane…
- Trial name
- NCT05477108
- Testing
- Treatment A (BGF MDI HFO with oral activated charcoal), Treatment B (BGF MDI HFA with oral activated charcoal)
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Contraception
Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)
The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the…
- Trial name
- NCT01253174
- Testing
- EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131), EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca), L-5-MTHF Ca 0.451 mg (Metafolin)
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bayer
Normal Healthy Subjects
An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different liposomal amphotericin B injections after single IV infusion at the same dose in normal healthy subjects.
- Trial name
- NCT01652859
- Testing
- Liposomal Amphotericin B, AmBisome
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Taiwan Liposome Company
Healthy
Fasting 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…
- Trial name
- NCT00649779
- Testing
- albuterol sulfate extended-release 8 mg tablets, VoSpire™ ER 8 mg tablets
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bacterial Infection
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
- Trial name
- NCT00939562
- Testing
- doxycycline monohydrate tablet, doxycycline carragenate tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions
Objective: To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects…
- Trial name
- NCT00939458
- Testing
- Lamotrigine
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy Volunteers
Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers
- Trial name
- NCT06359626
- Testing
- YHP2205, YHR2401
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Seizures
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fasted conditions.
- Trial name
- NCT01702623
- Testing
- Oxcarbazepine
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Propranolol Under Fasting Conditions
To compare the single-dose bioavailability of Propranolol 160 Mg ER capsules with Inderal-La
- Trial name
- NCT00653120
- Testing
- Propranolol, Inderal-LA
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy Subjects
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/1000 mg Relative to Originator
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
- NCT06233240
- Testing
- Sitagliptin and Metformin Hydrochloride Tablets Test product, Sitagliptin and Metformin Hydrochloride Tablets Reference product
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
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