Randomized Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2831781 in Healthy Japanese and White Participants
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DOI: 10.1002/cpdd.1165
Abstract: This study investigated ethnic differences in the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK2831781, an anti–lymphocyte activation gene 3 (LAG3) monoclonal antibody, in healthy participants, and determined local tolerability and bioavailability following subcutaneous (SC) administration.… read more here.
Keywords: tolerability pharmacokinetics; pharmacokinetics pharmacodynamics; white participants; japanese white ... See more keywords
Safety, Pharmacokinetics, and Pharmacodynamics of CC‐90001 (BMS‐986360), a c‐Jun N‐terminal Kinase Inhibitor, in Phase 1 Studies in Healthy Participants
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DOI: 10.1002/cpdd.1178
Abstract: CC‐90001 selectively inhibits c‐Jun N‐terminal kinase (JNK), a stress‐activated protein implicated in fibrosis. In 3 phase 1 trials evaluating CC‐90001 pharmacokinetics, pharmacodynamics, and safety, healthy adults (N = 184) received oral CC‐90001 in a single… read more here.
Keywords: safety; pharmacokinetics pharmacodynamics; jun terminal; phase ... See more keywords
Pharmacokinetics and Pharmacodynamics of Lansoprazole/Sodium Bicarbonate Immediate-release Capsules in Healthy Chinese Subjects: An Open, Randomized, Controlled, Crossover, Single-, and Multiple-dose Trial.
Sign Up to like & getrecommendations! Published in 2023 at "Clinical pharmacology in drug development"
DOI: 10.1002/cpdd.1251
Abstract: Proton pump inhibitors (PPIs) differ in onset of action and bioavailability. This trial was conducted to investigate the pharmacokinetics and pharmacodynamics of an immediate-release capsule formulation containing lansoprazole 30 mg and sodium bicarbonate 1100 mg (T preparation)… read more here.
Keywords: lansoprazole sodium; single multiple; pharmacokinetics pharmacodynamics; preparation ... See more keywords
Pharmacokinetics, Pharmacodynamics, and Safety of a Single Escalating Dose and Repeated Doses of Rasagiline Transdermal Patch in Healthy Chinese Subjects
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DOI: 10.1002/cpdd.761
Abstract: A rasagiline transdermal patch can be used to offer continuous rasagiline to patients with Parkinson's disease who cannot take their usual oral medications. This was the first study to investigate the pharmacokinetics, pharmacodynamics, and safety… read more here.
Keywords: pharmacodynamics safety; patch; transdermal patch; rasagiline transdermal ... See more keywords
Pharmacokinetics and Pharmacodynamics of Ursodeoxycholic Acid in an Overweight Population With Abnormal Liver Function
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.790
Abstract: Ursodeoxycholic acid (UDCA) is a secondary bile acid that is used to treat primary biliary cholangitis. Although UDCA has a hepatoprotective effect in some diseases, its benefit in nonalcoholic fatty liver disease (NAFLD) remains controversial.… read more here.
Keywords: liver function; udca 300; ursodeoxycholic acid; twice daily ... See more keywords
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral Venglustat in Healthy Volunteers
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DOI: 10.1002/cpdd.865
Abstract: Venglustat is a small‐molecule glucosylceramide synthase (GCS) inhibitor designed to reduce the production of glucosylceramide (GL‐1) and thus is expected to substantially reduce formation of glucosylceramide‐based glycosphingolipids. Because of its effect on glycosphingolipid formation, GCS… read more here.
Keywords: safety tolerability; safety; healthy volunteers; pharmacokinetics pharmacodynamics ... See more keywords
Safety, Pharmacokinetics, and Pharmacodynamics of a Dipeptidyl Peptidase‐4 Inhibitor: A Randomized, Double‐Blinded, Placebo‐Controlled Daily Administration of Fotagliptin Benzoate for 14 Days for Type 2 Diabetes Mellitus
Sign Up to like & getrecommendations! Published in 2021 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.895
Abstract: This study investigated the pharmacokinetics, pharmacodynamics, and safety of fotagliptin benzoate (fotagliptin), a dipeptidyl peptidase‐4 (DPP‐4) inhibitor, in Chinese patients with type 2 diabetes mellitus (T2DM). In a randomized, double‐blinded, placebo‐controlled study, 10 and 4… read more here.
Keywords: fotagliptin; dipeptidyl peptidase; type diabetes; pharmacokinetics pharmacodynamics ... See more keywords
Pharmacokinetics and pharmacodynamics of meldonium in exercised thoroughbred horses.
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DOI: 10.1002/dta.2214
Abstract: Although developed as a therapeutic medication, meldonium has found widespread use in human sports and was recently added to the World Anti-Doping Agency's list of prohibited substances. Its reported abuse potential in human sports has… read more here.
Keywords: exercised thoroughbred; thoroughbred horses; pharmacodynamics meldonium; meldonium exercised ... See more keywords
Safety, Pharmacokinetics, and Pharmacodynamics of the Oral TLR8 Agonist Selgantolimod in Chronic Hepatitis B
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DOI: 10.1002/hep.31795
Abstract: In patients with chronic hepatitis B (CHB) infection, activation of toll‐like receptor 8 may induce antiviral immunity and drive functional cure. Selgantolimod, a toll‐like receptor 8 agonist, was evaluated in patients with CHB who were… read more here.
Keywords: chronic hepatitis; hepatitis; agonist; pharmacokinetics pharmacodynamics ... See more keywords
Pharmacokinetics, Pharmacodynamics, and Tolerability of Concomitant Multiple Dose Administration of Verinurad (RDEA3170) and Allopurinol in Adult Male Subjects With Gout
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DOI: 10.1002/jcph.1119
Abstract: Verinurad (RDEA3170) is a selective uric acid reabsorption inhibitor in clinical development for treatment of hyperuricemia and gout. This phase 1b, multiple‐dose, drug‐drug interaction study evaluated the pharmacokinetics, pharmacodynamics, and tolerability of verinurad in combination… read more here.
Keywords: verinurad allopurinol; verinurad; multiple dose; pharmacodynamics tolerability ... See more keywords
FAME‐04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir
Sign Up to like & getrecommendations! Published in 2018 at "Journal of the International AIDS Society"
DOI: 10.1002/jia2.25156
Abstract: Fast‐dissolving vaginal film formulations release antiretroviral drugs directly into vaginal fluid and may be as efficient at drug delivery yet more acceptable to women than gels. In this Phase 1 vaginal film study, the safety,… read more here.
Keywords: pharmacokinetics pharmacodynamics; acceptability pharmacokinetics; safety acceptability; film ... See more keywords