Clinical trials: Estrogen Receptor Negative
- Condition Estrogen Receptor Negative
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Healthy
Bioequivalence Study of Minocycline HCl 135 mg ER Tablet Sunder Fed Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline hydrochloride extended release tablets 135 mg…
- Trial name
- NCT02312609
- Testing
- Minocycline hydrochloride
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 milligram [mg]) with respect to the Tylenol 8 hour (H) extended-release (ER) tablet (acetaminophen 650 mg) in…
- Trial name
- NCT04214691
- Testing
- Acetaminophen
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Janssen Korea, Ltd., Korea
Pain
Naproxen Sodium ER Pharmacokinetic Study
To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.
- Trial name
- NCT00818415
- Testing
- Naproxen sodium ER (BAYH6689), Commercial Naproxen (Aleve, BAYH6689)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Schizophrenia
A Positron-Emission-Tomography (PET) Study to Measure the Blockade of Dopamine Receptors (D2) in Specific Areas of the Brain in Relation to the Plasma Concentrations of Paliperidone Extended Release (ER) and Oral Risperidone in Schizophrenia Patients and Healthy Controls
The primary objective of this study is to compare the effect of two different antipsychotic compounds which are used in the treatment of schizophrenia (paliperidone ER and risperidone) at their target sites in two specific areas…
- Trial name
- NCT00934635
- Testing
- Paliperidone ER, Oral risperidone, PET Scan
- Where
- Germany
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Janssen-Cilag G.m.b.H
Renal Impairment
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment
Determine the influence of renal impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
- Trial name
- NCT02244762
- Testing
- 20 mg HC-ER
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Zogenix, Inc.
Healthy
Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under…
- Trial name
- NCT00649129
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
Healthy
Metformin ER 750 mg Tablets, Fed
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fed conditions.
- Trial name
- NCT00834613
- Testing
- Glucophage® XR 750 mg Tablets, Metformin ER 750 mg Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Allergies
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fed conditions.
- Trial name
- NCT00881634
- Testing
- Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA), Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sandoz
Schizophrenia
A Study of the Effect of Food and Posture on the Pharmacokinetics of a Single Dose of ER OROS Paliperidone
The purposes of this study are to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy men, and to evaluate the effect of posture on the pharmacokinetics of ER OROS…
- Trial name
- NCT00838669
- Testing
- Extended release OROS paliperidone
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Pharmacokinetics
Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)
A single dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is solution is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release (ER) capsule prototypes.
- Trial name
- MPAR-101 (NCT05090280)
- Testing
- PF614 solution, Naltrexone Hydrochloride, Nafamostat Mesylate
- Where
- United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Ensysce Biosciences
Healthy
Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects
The purpose of this study is to determine if the relative difference in PK between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
- Trial name
- NCT00329186
- Testing
- desvenlafaxine SR, venlafaxine ER
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Bladder Cancer
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER capsules in comparison to APL-1202 IR tablets.
- Trial name
- NCT06034015
- Testing
- APL-1202 and APL-1501 (Single ascending dose), APL-1202 and APL-1501 (Multiple Ascending dose)
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Healthy
Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)
The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects.
- Trial name
- NCT00941239
- Testing
- metformin ER, metformin
- Where
- Mexico
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Pharmacokinetics
A Study to Explore Plasma Levels of CONCERTA, Ritalin-SR and Novo-Methylphenidate ER-C in Healthy Volunteers
This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24 hour period after they take this medication.
- Trial name
- NCT01118702
- Testing
- Ritalin-SR, Concerta, Novo-Methylphenidate ER-C
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Janssen-Ortho Inc., Canada
Type 2 Diabetes Mellitus
A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites (0524A-079)(COMPLETED)
The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a specific metabolite (which is a marker of in vivo…
- Trial name
- NCT00618995
- Testing
- Comparator: ER niacin (+) laropiprant, Comparator: ER niacin, Comparator: laropiprant
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452
The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to…
- Trial name
- NCT05722262
- Testing
- K-001, K-877-ER, CSG452
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Kowa Research Institute, Inc.
Healthy
Bioequivalence Study of Torrent Pharmaceutical Limited's Isosorbide Mononitrate 120 mg ER Tablets Under Fed Conditions
Objective: to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA under fed condition.
- Trial name
- NCT01418547
- Testing
- Torrent's Isosorbide Mononitrate 120 mg ER Tablets
- Where
- 2 sites in India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended release tablets USP 10 mg (containing felodipine…
- Trial name
- NCT02327247
- Testing
- Felodipine, PLENDIL®
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited