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Relative Oral Bioavailability and Food Effects of Two Sepiapterin Formulations in Healthy Participants
This study characterized the pharmacokinetics, safety, and tolerability of 2 clinical sepiapterin formulations (Phase 1/2, Phase 3) and the effects of food on the pharmacokinetics of the Phase 3 formulation in healthy participants. In Part A, 18 participants were randomized to one of 2 treatment sequences, each with 4 dosing periods comprising a single dose (20 or 60  mg/kg) of the Phase 1/2 or the Phase 3 formulation with a low-fat diet. In Part B, 14 participants were randomized to one of 2 sequences, each comprising 4 dosing periods of a single dose (20 or 60 mg/kg) of the Phase 3 formulation under fed (high-fat) or f...
Source: Clinical Pharmacology in Drug Development - December 29, 2023 Category: Drugs & Pharmacology Authors: Lan Gao, Diksha Kaushik, Yi Xia, Kimberly Ingalls, Sarah Milner, Neil Smith, Ronald Kong Tags: Original Article Source Type: research

Population Pharmacokinetic Modeling and Simulation of Pudexacianinium (ASP5354) for Dose Setting of a Phase 2 First ‐in‐Patient Study: A Novel Imaging Agent for Intraoperative Ureter Visualization during Abdominopelvic Surgery
The objective of the present analysis was to determine appropriate doses of pudexacianinium for a phase 2, dose-ranging study (NCT04238481). Real-time urine pudexacianinium concentration is considered a good pharmacodynamic surrogate marker, since ureter visualization likely depends on its concentration in the ureter. Using plasma and urine concentrations of pudexacianinium from a phase 1 single-ascending-dose (0.1-24.0  mg) study in healthy participants, a 3-compartment population pharmacokinetic model with a urine output compartment was developed and effectively described the concentration-time profiles. The individual ...
Source: Clinical Pharmacology in Drug Development - December 23, 2023 Category: Drugs & Pharmacology Authors: Masako Saito, Tomoki Kojima, Kanji Komatsu, Shin Takusagawa Tags: Original Article Source Type: research

Safety, Tolerability, and Pharmacokinetics of a Novel Oral Phosphodiesterase 4 Inhibitor, ME3183: First ‐in‐Human Phase 1 Study
AbstractA novel, oral phosphodiesterase 4 (PDE4) inhibitor, ME3183, is under development for the treatment of psoriasis, atopic dermatitis, and other inflammatory diseases. To evaluate its safety, tolerability, and pharmacokinetics, double-blind, placebo-controlled, single ascending dose (SAD), and multiple ascending dose (MAD) phase 1 studies were conducted in 126 healthy adults. The food effect was evaluated in a randomized, open-label, crossover manner (n = 5). ME3183 was safe and tolerable up to 25  mg in the SAD part and up to 10 mg twice daily in the MAD part. Frequently observed treatment-emergent adverse events i...
Source: Clinical Pharmacology in Drug Development - December 19, 2023 Category: Drugs & Pharmacology Authors: Seiji Kato, Naoki Cho, Tomokazu Koresawa, Kazunari Otake, Akiko Kano Tags: Original Article Source Type: research

Population ‐Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3‐71, a Novel Sigma‐1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease
AbstractPharmacokinetic (PK) data from 28 subjects who received 5-200-mg single ascending doses of ANAVEX3-71, formerly AF710B, were analyzed to characterize the PK of ANAVEX3-71 and its M8 metabolite. PK data from 12 subjects who received 160  mg ANAVEX3-71 under fed and fasted conditions were analyzed to characterize the effect of food on the PK of the drug and its M8 metabolite. PK was characterized using the standard 2-stage approach and the nonlinear mixed-effects modeling approach. Dose proportionality was determined using the powe r model. Two- and 3-compartment linear PK models were tested for the characterization...
Source: Clinical Pharmacology in Drug Development - December 12, 2023 Category: Drugs & Pharmacology Authors: Emmanuel O. Fadiran, Edward Hammond, James Tran, Christopher U. Missling, Ene Ette Tags: Original Article Source Type: research

A Randomized, Single ‐Dose, Parallel‐Controlled Phase I Clinical Comparison of an Omalizumab Biosimilar Candidate with Reference Omalizumab in Healthy Chinese Male Volunteers
This study evaluated the bioequivalence of omalizumab, a humanized monoclonal antibody against immunoglobulin-E (IgE), with one of its biosimilar candidates. The study was designed as a randomized, double-blind, parallel-controlled trial. A total of subjects who met the inclusion criteria and did not meet the exclusion criteria were dynamically randomly assigned to receive the test drug or the reference drug with a single subcutaneous injection of 150  mg by the minimization method. The test group and the reference group had similar demographic characteristics and baseline characteristics of total IgE. The 90% confidence ...
Source: Clinical Pharmacology in Drug Development - December 6, 2023 Category: Drugs & Pharmacology Authors: Jie Cheng, Chenguang Wang, Jin Xu, Chunyang Zhao, Rong Song, Yijun Wang, Yang Zou, Xunmin Zhang, Yong Shan, Jian Zhou, Jing ‐Ying Jia Tags: Original Article Source Type: research

Issue Information
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - December 1, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research

Support for Removing Pharmacodynamic and Clinical Efficacy Testing of Biosimilars: A Critical Analysis
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - December 1, 2023 Category: Drugs & Pharmacology Authors: Sarfaraz K. Niazi Tags: Commentary Source Type: research

Issue Information
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - December 1, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research

Pharmacological Parameters and Pharmacokinetic Variability Derived from Bioequivalence Trials in a Mexican Population
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - November 28, 2023 Category: Drugs & Pharmacology Authors: Carlos Alejandro D íaz‐Tufinio, Vanessa Gonzalez‐Covarrubias, José Antonio Palma‐Aguirre Tags: Commentary Source Type: research

Pharmacokinetics and Bioequivalence of Amlodipine Besylate Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions
AbstractThe purpose of this study was to compare the blood concentration and pharmacokinetic (PK) parameters of 2 formulations under fasting and ed conditions in healthy Chinese volunteers and to evaluate whether the 2 preparations were bioequivalent. This trial screened 170 subjects. Thirteen subjects were assigned to the fasting trial and 18 subjects to the fed trial; 1 subject in the fed trial group was automatically withdrawn for personal reasons. Two cycles had a 14-day washout period. This clinical study was a bioequivalence study, with PK parameters as end point indicators. The bioequivalence PK parameters were the ...
Source: Clinical Pharmacology in Drug Development - November 24, 2023 Category: Drugs & Pharmacology Authors: Liyuan Tang, Yanrong Wang, Ran Chen, Yuanyuan He, Ying Liu, Na Wang, Xiaoyan Sun, Jingya Song Tags: Original Article Source Type: research

Bioequivalence Study of Capsules versus Film Tablets Containing Rivaroxaban in Healthy Caucasian Subjects under Fasting and Fed Conditions
AbstractThe bioequivalence (BE) of orally administered capsules versus film tablets containing 20   and 10 mg of rivaroxaban was assessed in 2 single-dose, open-label, randomized 2-way crossover trials with a washout period of at least 1 week. The study for the 10 mg strength was conducted under fasting conditions (n = 68) and the study for the 20 mg strength under fed conditions (n = 52). B lood samples were collected over a 36-hour period and concentrations were assayed using a liquid chromatography tandem mass spectrometry method. Pharmacokinetic (PK) evaluation was performed with the program Phoenix WinNonlin, for ...
Source: Clinical Pharmacology in Drug Development - November 24, 2023 Category: Drugs & Pharmacology Authors: G ökçe Sözer, Ahmet Inal, Zafer Sezer, Wolfgang Martin, Ewald Ottmann, Martin Reinsch, Selma Alime Koru Tags: Original Article Source Type: research