Clinical trials: Pharmaceutical Preparations
Infections, Bacterial
Amoxicillin Bioequivalence Study Brazil - Fast
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the…
- Trial name
- NCT01431989
- Testing
- Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL, Amoxil® 500mg/5mL powder for oral suspension
- Where
- Brazil
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
- Trial name
- NCT00939367
- Testing
- Zolpidem Tartrate Tablets 10 mg, 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Dental Research, Pharmaceutical Preparations, Dental
The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess
An individual's quality of life can be seriously affected by the severity of dental pain. The emergency department is a common place to find those seeking relief from their dental pain- often times seeking removal of the affected…
- Trial name
- NCT03005522
- Testing
- oral dexamethasone
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- University of Arizona
Hearing Loss, Noise-Induced
Noise-Induced Hearing Loss-Acute Exposure Treatment
The purpose of this study is to assess the safety and efficacy of zonisamide for the treatment of noise-induced hearing loss in adults.
- Trial name
- PINIHL-AET (NCT04768569)
- Testing
- Zonisamide 100Mg Cap
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Viral Infection
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of…
- Trial name
- UV (NCT02061358)
- Testing
- UV-4B 3 mg, UV-4B 10 mg, UV-4B 30 mg
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Pain
Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye
Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine…
- Trial name
- NCT01087489
- Testing
- 4% lidocaine, 3.5% ophthalmic lidocaine gel
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Miami VA Healthcare System
Atropine Bioequivalence
Sublingual Atropine Bioequivalence by Route of Administration (SABER)
A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult…
- Trial name
- SABER (NCT06366087)
- Testing
- Atropine Sulfate Ophthalmic Solution USP, 1%, Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL)
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Biomedical Advanced Research and Development Authority
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
- Trial name
- NCT02014272
- Testing
- RIN 150, reference drugs
- Where
- Singapore
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine])…
- Trial name
- NCT05014490
- Testing
- Exib 120 mg etoricoxib film-coated tablets, Arcoxia® 120 mg etoricoxib film-coated tablets
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fed Conditions
Objective: Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test…
- Trial name
- NCT00939705
- Testing
- topiramate
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Degenerative Disc Disease
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in…
- Trial name
- MSB-DR003 (NCT02412735)
- Testing
- Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture
- Where
- 48 sites in United States, Australia
- Volunteers
- 404 people
- Sponsor
- Mesoblast, Ltd.
Hearing Loss, Noise-Induced
Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)
The purpose of this study is to assess the safety and efficacy of zonisamide (ZNS) for the treatment of noise-induced hearing loss in adults.
- Trial name
- PINIHL-AET (NCT04774250)
- Testing
- Zonisamide 100Mg Cap
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Prader-Willi Syndrome
A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome
The objective of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in participants with Prader-Willi Syndrome.
- Trial name
- NCT03458416
- Testing
- Cannabidiol Oral Solution
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Anesthesia, General
Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane
This registry is primarily aiming to demonstrate the correlation between good practices of anesthesiologists and patient related outcomes including decreased overall anesthesia cost.
- Trial name
- NCT01199471
- Where
- 40 sites in China
- Volunteers
- 4,000 people
- Sponsor
- Abbott
Depression
Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care
The purpose of this study is to evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression.
- Trial name
- PRODEFAR (NCT00794196)
- Testing
- Pharmaceutical care program for antidepressant treatment
- Where
- 2 sites in Spain
- Volunteers
- 179 people
- Sponsor
- Fundació Sant Joan de Déu
Obesity, Overweight
A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects
The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.
- Trial name
- NCT00532779
- Testing
- Naltrexone SR 16 mg/Bupropion SR 360 mg /day, Naltrexone SR 32 mg/Bupropion SR 360 mg /day, Ancillary therapy
- Where
- 34 sites in United States
- Volunteers
- 1,742 people
- Sponsor
- Orexigen Therapeutics, Inc
Viral Infection
Safety and Pharmacokinetics of UV-4B Solution Administered Orally as Multiple Ascending Doses to Healthy Subjects
The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral solution when administered to healthy subjects three times a day (TID) for 7 days.
- Trial name
- NCT02696291
- Testing
- UV-4B 30 mg oral solution, UV-4B 75 mg oral solution, UV-4B 150 mg oral solution
- Where
- 2 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Healthy Volunteers
A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules
The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg dexlansoprazole manufactured at TPC (Takeda…
- Trial name
- NCT03801148
- Testing
- 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC, 60 mg dexlansoprazole capsules manufactured at TOB
- Where
- United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fasted Conditions
Objective: To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: Ambien® Tablets 10 mg (Reference…
- Trial name
- NCT00939536
- Testing
- Zolpidem Tartrate Tablets 10 mg
- Where
- India
- Volunteers
- 24 people
- Sponsor
- Torrent Pharmaceuticals Limited
Presbyopia, Refractive Errors
Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
- Conditions
- Presbyopia, Refractive Errors, Eye Diseases
- Trial name
- NCT05294328
- Testing
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Vehicle Proprietary Ophthalmic Solution
- Where
- 5 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- LENZ Therapeutics, Inc