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The main objectives of this study are to determine the bioequivalence of the hormones (example, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component, evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component and show non-inferior adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component.
EVRA patch (NGMN+EE) (Treatment A) (Reference), High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
SGS Belgium NV
Not yet recruiting
Janssen Research & Development, LLC
Published on BioPortfolio: 2019-07-17T10:04:58-0400
The purpose of this study is to determine the bioequivalence of the hormones (ie, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch and to evaluate...
Investigators propose a descriptive pharmacokinetic study of the serum hormone levels of estrogen and progesterone with extended use (12 weeks) of the contraceptive patch. The primary obje...
The objective of this study is to compare the levels of the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers administered ORTHO EV...
A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)
An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an ...
A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA® (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST® (an Oral Contraceptive)
The objective of this study is to estimate exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in healthy female volunteers across multiple commercial lots of EVRA®...
Investigation of the permeation enhancer strategy on benzoylaconitine transdermal patch: The relationship between transdermal enhancement strength and physicochemical properties of permeation enhancer.
Permeation enhancer strategy is used to develop Benzoylaconitine (BA) of high molecular weight (603.7 Da) into transdermal patch. The present study was to achieve a patch with good analgesic and ant...
We reported in previous study that the photodynamic therapy (PDT) of Helicobacter pylori(H. pylori) could more potentiate the bactericidal effect by adding chitosan. As a next step, we investigated to...
Municipal solid waste (MSW) incineration is widely used in China. Concentrated leachate, containing high concentrations of pollutants, is an important type of secondary pollution produced in MSW incin...
Childhood obesity has become a major health problem in children under the age of 5 years. Providing reference standards would help paediatricians to detect and/or prevent health problems related to bo...
Rising use of prescription opioids is a major public health concern associated with increased risk of mortality worldwide. Fentanyl, a synthetic opioid available in patch form, is particularly concern...
An electrophysiologic technique for studying cells, cell membranes, and occasionally isolated organelles. All patch-clamp methods rely on a very high-resistance seal between a micropipette and a membrane; the seal is usually attained by gentle suction. The four most common variants include on-cell patch, inside-out patch, outside-out patch, and whole-cell clamp. Patch-clamp methods are commonly used to voltage clamp, that is control the voltage across the membrane and measure current flow, but current-clamp methods, in which the current is controlled and the voltage is measured, are also used.
A low-molecular-weight protein (minimum molecular weight 8000) which has the ability to inhibit trypsin as well as chymotrypsin at independent binding sites. It is characterized by a high cystine content and the absence of glycine.
A process of selective diffusion through a membrane. It is usually used to separate low-molecular-weight solutes which diffuse through the membrane from the colloidal and high-molecular-weight solutes which do not. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
A heterodimeric protein complex of RNA cap-binding proteins, which binds with high affinity to the 5' MRNA CAP STRUCTURE in the CELL NUCLEUS. The complex contains two subunits, one of 80-kDa molecular weight and another of 20-kDa molecular weight.
A plasma protein, molecular weight of 110 kD, that normally exists in plasma in a 1:1 complex with PREKALLIKREIN. HMWK is split by plasma kallikrein to produce BRADYKININ. The complex is a cofactor in the activation of coagulation factor XII. The product of this reaction, XIIa, in turn activates prekallikrein to KALLIKREINS. (From Stedman, 26th ed)