[A multi-center, randomized, controlled, double blind and double dummy clinical trial of antofloxacin hydrochloride tablet versus levofloxacin tablet for the treatment of acute bacterial infections].

Objective: To evaluate the clinical efficacy and safety of antofloxacin hydrochloride tablet for the treatment of acute bacterial infections.

Methods: A multi-center randomized control, double blind and double dummy clinical trial was conducted; levofloxacin tablet was closed as controlled drug. The duration of treatment was 7-14 days in both groups.

A sensitive and practical LC-MS/MS method for the determination of mizoribine in human serum and its bioequivalence study on Chinese healthy volunteers.

A high-performance liquid chromatography/electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) method was developed and validated for the determination of mizoribine in human serum using thiamphenicol as internal standard (IS). The serum samples of mizoribine were precipitated with acetonitrile and separated by HPLC on a reversed phase C18 column with a mobile phase of 0.1% ammonium acetate water solution-methanol (47:53, v/v).

Pharmacokinetics and bioequivalence study of valacyclovir hydrochloride capsules after single dose administration in healthy Chinese male volunteers.

The aim of the present study was to compare the bioavailability of valacyclovir (CAS 124832-26-4; INN: valaciclovir) from two valacyclovir hydrochloride (CAS 214832-27-5) capsules (150 mg/capsule as test preparation and 150 mg/capsule commercially available original capsule of the drug as reference preparation) in 20 Chinese healthy male volunteers, aged between 20 and 27. The study was conducted according to an open, randomized, single blind, 2-way crossover study design with a wash-out phase of 7 days. Blood samples for pharmacokinetic profiling were taken up to 24 h post-dose.

Bioequivalence of two tablet formulations of helicidum adminstered in single dose to healthy Chinese volunteers.

In this 2 x 2, randomized, crossover bioequivalence study, two tablet preparations of helicidum were compared in 20 healthy Chinese male subjects. The drug was given in a single dose of three tablets (75 mg) and blood samples were withdrawn during 12 h after drug administration. Helicidum was separated and analyzed using a validated liquid chromatography-mass spectrum method.

[Phase II randomized clinical trail of zoledronic acid in treating metastatic bone pain of malignancy].

Background & Objective: Bone metastases are the prevailing reason for pain in patients with malignancies, which seriously affect their life quality. Zoledronic acid, the third generation of bisphosphonates, can inhibit the activity of osteoclasts and relieve pain. This study was to evaluate the efficacy and safety of zoledronic acid in treating metastatic bone pain for patients with malignancies.

Determination of loratadine in human plasma by HPLC with fluorescence detector and study on its bioavailability.

Aim: To establish an HPLC-fluorescence method for determination of loratadine in human plasma and evaluate its relative bioavailability.

Methods: An Alltech-C18 column and a mobile phase of acetonitrile-water-glacial acetic acid-triethylamine (90:100:6:0.15) were used.