Clinical trials: Therapeutic Equivalency, Healthy
Bioequivalence
Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Long Merck )
- Trial name
- NCT03452306
- Testing
- Metformine, Glucophage® Long, Metformin
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Geropharm
Healthy
Praziquantel Bioequivalence Study
The purpose of this trial is to assess the bioequivalence (BE) of new 600 milligram (mg) Cisticid tablet (Test) versus 600 mg Biltricide tablets (Reference) at a dose of 1200 mg in healthy male participants.
- Trial name
- NCT03437447
- Testing
- Cisticid, Biltricide
- Where
- Mexico
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy Volunteers
Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects
The purpose of this study is to evaluate the bioequivalence (comparison of the rate and extent of the active substance into the body following single administration of the drugs) between the test product V0057 and a reference…
- Trial name
- NCT01861626
- Testing
- V0057 - A mg, Isotretinoin
- Where
- Germany
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Dermatology
Bioequivalence
Bioequivalence Study of Two Formulations of Sildenafil Tablet 100 mg in Healthy Male Volunteers Under 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 (Viagra®, 100 mg film-coated tablets) or the…
- Trial name
- NCT04882826
- Testing
- Sildenafil film-coated tablet 100 mg, Viagra® film-coated tablet 100 mg
- Where
- Russia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Diabetes, Diabetes Mellitus, Type 2
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.
- Trial name
- NCT01527630
- Testing
- biphasic insulin aspart 50
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
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
Bioequivalence
Characterisation of Relative Bioavailability With Bioequivalence Assessment of Deferiprone Tablets After Oral Single Dose Administration
The present study will be conducted in order to compare the bioavailability of the generic Test product (Deferiprone 500 Lipomed tablets, Lipomed AG, Switzerland) with a marketed Reference product (Ferriprox® film-coated tablets…
- Trial name
- NCT02980458
- Testing
- Deferiprone 500Mg Tablet, Deferiprone 500 MG Oral Tablet [Ferriprox]
- Where
- Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- SocraTec R&D GmbH
Healthy Adult Volunteers
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.
This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers.
- Trial name
- NCT05162274
- Testing
- Lazertinib(G001), Lazertinib(G002)
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Bioequivalence
Bioequivalence Study of Lopinavir/Ritonavir 200/50 mg Film Tablet (World Medicine Ilac, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg lopinavir and 50 mg ritonavir fixed dose combination and a single dose of Test product containing 200 mg lopinavir and 50 mg ritonavir fixed dose combination or vice versa…
- Trial name
- Orvical (NCT04386876)
- Testing
- Lopinavir/Ritonavir 200 mg/50 mg Film Tablet, Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- World Medicine ILAC SAN. ve TIC. A.S.
Healthy
Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
- Trial name
- NCT02767310
- Testing
- Rosuvastatin 20 mg film-coated tablets, Crestor 20 mg film-coated tablets
- Where
- India
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
Healthy
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions
This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating…
- Trial name
- NCT01260948
- Testing
- Donepezil Hydrochloride, Aricept®
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Levetiracetam 1000 mg Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of an investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the commercially available reference product under fed…
- Trial name
- NCT00859430
- Testing
- Levetiracetam, Keppra®
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bacterial Infections
Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule
To assess the relative bioavailability of two different batches of Frademicina® drug product, containing 500 mg lincomycin hydrocloride, manufactured by Pfizer Laboratories Ltd.
- Trial name
- NCT01058824
- Testing
- Lincomycin
- Where
- 2 sites in Brazil
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Dietary Exposure
Bioequivalence Study on Vitamin C in Healthy Adults
The objective of this exploratory pharmacokinetic research study is to demonstrate that both caplets and gummies provide an effective dose of ascorbic acid in healthy adults.
- Trial name
- NCT03562988
- Testing
- Vitamin C gummy, Vitamin C tablet
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Church & Dwight Company, Inc.
Healthy
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.
- Trial name
- NCT01101191
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy
A Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare, Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland)
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) versus Sovaldi 400 mg F.C.T (Gilead Sciences…
- Trial name
- NCT02491450
- Testing
- Heterosofir, Sovaldi
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Atopic Dermatitis
Evaluation of TLL-018 Extended and Immediate Release Formulation for Bioequivalence Testing in Healthy Chinese Subjects
The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single…
- Trial name
- NCT05945810
- Testing
- TLL-018 extended-release tablet, TLL-018 immediate-release tablet
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
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
Healthy
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy…
- Trial name
- NCT03566810
- Testing
- Test GXR, Reference GXR
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Terbinafine HCl 250 mg Tablet Under Fasting Conditions
The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in…
- Trial name
- NCT00833586
- Testing
- Terbinafine HCl 250mg tablets, Lamisil® 250 mg Tablets
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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