ABSTRACT
Objective: The purpose of this study is to determine the bioequivalence of a 75 mg dose of venlafaxine hydrochloride extended release capsule formulations between the test product (Valosine® S.R., Standard Chem. & Pharm. Co., Ltd., Taiwan) and the reference product (Efexor®-XR, Wyeth-Ayerst Ireland Co., Ltd). Methods: An open-labeled, multiple-dose with food, 2-treatment, 2-period, 2-sequence, randomized crossover study was conducted in 24 healthy Thai volunteers. Each volunteer received a 75 mg capsule of the reference or test drugs for 6 consecutive days. On the 6th day of dosing, blood samples were collected before dosing at various time points up to 24 hours after dosing and on the other days (the 1st, 4th and 5th day of dosing) pre-dose blood samples were also collected for steady state confirmation. Analysis of venlafaxine concentrations was performed using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters including Cssmax, AUC0-24(ss), Tssmax and t1/2 were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. Results: Twenty-three volunteers completed both treatment periods. The geometric mean ratios (Test/Reference) between the two products of extended-release venlafaxine capsule were 88.80% (81.46%-96.80%) for Cssmax ratios and 101.10% (95.02%-107.56%) for AUC0-24(ss) ratios. There was no significant difference of the Tssmax parameter between the two formulations (p >0.05). No serious adverse events related to the study drugs were found. Conclusion: The two products of venlafaxine hydrochloride extended release capsules are bioequivalent. Both products are well tolerated.
ABSTRACT
Objective: Netilmicin, a broad-spectrum semisynthetic aminoglycoside antibiotic, is used in the treatment of a wide variety of bacterial infections. The purpose of this study is to compare the bioavailability of two products of 150 mg netilmicin by intramuscular administration in Thai healthy volunteers: The generic drug is Nelin® (test; Biolab Co., Ltd., Thailand) will be called “Test” and Netromycin® (reference; Schering-Plough Ltd., USA) will be called “Reference”. Methods: A single-dose, 2-treatment, 2-period, 2-sequence, randomized crossover study was conducted in 24 healthy Thai volunteers. Each volunteer received a 150 mg intramuscular injection of the reference or test drugs. Blood samples were collected before dosing and at various time points up to 48 hours after dosing and analyzed for netilmicin concentrations using a validated liquid chromatography-mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters including Cmax, AUC0-t, AUC0-¥, Tmax and t1/2 were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. Results: Twenty-four volunteers completed both treatment periods. The geometric mean ratios (test/reference) between the two products of netilmicin were 100.30% (90% CI, 88.02%-114.28%) for Cmax, 94.94% (90% CI, 88.94%-101.34%) for AUC0-t, and 94.88% (90% CI, 88.85%-101.32%) for AUC0-¥. There was no significant difference of the Tmax values between the two studied products (P>0.05). No adverse events related to the study drugs were found. Conclusion: The two products of intramuscular netilmicin are bioequivalent. Both products are well tolerated.
ABSTRACT
OBJECTIVE: To compare the bioequivalent parameters of 30 mg pioglitazone tablets manufactured locally (Glista) and originally (Actos). MATERIAL AND METHOD: A randomized, single dose, two-treatment, two-period, two-sequence crossover study was conducted Twenty-four healthy volunteers were recruited at Siriraj Clinical Research Unit. Each subject received a 30 mg pioglitazone tablet of both formulations with at least a week washout period Blood samples were collected over 48 h after the oral administration. The plasma fractions were analyzed for pioglitazone using a liquid chomatography-mass spectrometry (LC-MS/MS). RESULTS: Twenty-four volunteers enrolled in the present study. Pharmacokinetic parameters were determined using the non-compartment model. The 90 percent confidence intervals of the mean ratios (test/reference) of Cmax (86.2687-113.7313%), A UC0-->t(85. 7139-114.2861%) and AUC0-->infinity (81.7820-118.2180%) fell within the acceptable range (80-125%) for bioequivalent eligibility. Both preparations were well tolerated and had afew non-serious adverse events. CONCLUSION: The 2-tablet preparations of pioglitazone were bioequivalent in Thai healthy volunteers.