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Bioequivalence of 2 Aripiprazole Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2021; 10 (8)

To assess the bioequivalence of 2 formulations of aripiprazole orally disintegrating tablets and to monitor their safety and tolerability in Chinese s......

Human Mass Balance and Metabolite Profiling of [C-14]-Pamiparib, a Poly (ADP-Ribose) Polymerase Inhibitor, in Patients With Advanced Cancer

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2021; 10 (9)

Pamiparib, a selective poly (ADP-ribose) polymerase 1/2 inhibitor, demonstrated tolerability and antitumor activity in patients with solid tumors at 6......

Pharmacokinetics and Safety of Dapoxetine Hydrochloride in Healthy Chinese Men: Impact of Dose and High-Fat Meal

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, ; ()

Dapoxetine is the first oral medication specifically developed for the on-demand treatment of premature ejaculation. The pharmacokinetics and safety o......

Evaluation of the Bioequivalence of Acarbose in Healthy Chinese People

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, ; ()

The purpose of this study was to determine whether the reference formulation and test formulation of acarbose are bioequivalent among healthy Chinese ......

Comparison of the Pharmacokinetics of Generic Versus Branded Obeticholic Acid in a Chinese Population: Effects of Food and Sex

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, ; ()

The present study assessed the pharmacokinetics and bioequivalence of a single 10-mg dose of a generic and the branded formulation (Ocaliva) of obetic......

Safety, Tolerability, and Pharmacokinetics of Multiple Repeated Oral Doses of the alpha 2/3/5-Subtype Selective GABA(A)-Positive Allosteric Modulator PF-06372865 in Healthy Volunteers

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, ; ()

Multiple-dose pharmacokinetics (PK) and safety were investigated in this phase 1 study of PF-06372865, a positive allosteric modulator of alpha 2/3/5 ......

Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2021; 10 (3)

Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We characterized tofacitinib pharmacokinet......

Pharmacokinetics of Single and Multiple Doses of Omega-3 Carboxylic Acids in Healthy Chinese Subjects: A Phase I, Open-Label Study

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2020; 9 (8)

In patients with coronary heart disease undergoing primary prevention, hypertriglyceridemia is a residual risk for cardiovascular events. Omega-3 carb......

Pharmacokinetics, Safety, and Tolerability of Single- and Multiple-Dose Once-Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo-Controlled Study

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2020; 9 (8)

The objective of this phase 1 study was to evaluate the pharmacokinetics, safety, and tolerability of baricitinib after single and multiple doses in h......

Pharmacokinetic Properties of Single and Multiple Doses of Ertugliflozin, a Selective Inhibitor of SGLT2, in Healthy Chinese Subjects

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2020; 9 (1)

Ertugliflozin, a sodium-glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes mellitus, prevents renal glucose reabsorption resulting......

Bioequivalence of Ertugliflozin/Metformin Fixed-Dose Combination Tablets and Coadministration of Respective Strengths of Individual Components

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2020; 9 (1)

A fixed-dose combination (FDC) of ertugliflozin, a selective sodium-glucose cotransporter 2 inhibitor, and immediate-release metformin is approved for......

The Bioequivalence of Tafamidis 61-mg Free Acid Capsules and Tafamidis Meglumine 4 x 20-mg Capsules in Healthy Volunteers

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2020; 9 (7)

Tafamidis, a non-nonsteroidal anti-inflammatory benzoxazole derivative, acts as a transthyretin (TTR) stabilizer to slow progression of TTR amyloidosi......

Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects

期刊: CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2020; 9 (5)

Sildenafil citrate is approved to treat erectile dysfunction. An orally disintegrating tablet (ODT) of sildenafil citrate that does not require swallo......

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