Apixaban Pharmacokinetics and Bioequivalence of Two Tablet Formulations: A Randomized, Open-Label, Crossover Study, Fasting Condition in Healthy Indonesian Volunteers.

The present study aimed to assess the bioequivalence of a new apixaban generic with reference formulation. Twenty-six healthy volunteers were recruited for an open-label, balanced, randomized, 2-treatment, 2-sequence, 2-period, single oral dose study. Following overnight fasting, each volunteer received 5 mg of apixaban test and reference formulations as single doses, separated by a 1-week washout period.

Single dose pharmacokinetic equivalence study of two gabapentin preparations in healthy subjects.

Background: The current study was conducted to find out whether two oral preparations of 300 mg gabapentin (the test and reference capsules) were bioequivalent.

Subjects And Methods: This was a randomized, single-blind, crossover study under fasting condition, with a 7-day washout period, which included 37 healthy adult male and female subjects. After an overnight fast, subjects were given, orally, one capsule of the test drug or of the reference drug.

Bioequivalence study of two formulations of candesartan cilexetil tablet in healthy subjects under fasting conditions.

Introduction: The present study was conducted to compare the bioavailability of two candesartan cilexetil 16 mg tablet formulations (test and reference formulations).

Materials And Methods: This study was a randomized, single- blind, two-period, cross-over study which included 24 healthy adult male and female subjects under fasting conditions. The pharmacokinetic parameters were determined based on the concentrations of candesartan (CAS 139481-59-7), using ultra-pressure high-performance liquid chromatography with a tandem mass spectrometer detector.

Bioequivalence study of two formulations of bisoprolol fumarate film-coated tablets in healthy subjects.

Background: The present study was conducted to compare the bioavailability of two bisoprolol fumarate 5 mg film-coated tablet formulations (test and reference formulations).

Patients And Methods: This study was a randomized, single-blind, two-period, two-sequence crossover study that included 18 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters were determined based on the concentrations of bisoprolol (CAS 66722-44-9), using ultraperformance liquid chromatography with a tandem mass spectrometer detector.

Bioequivalence study of two clopidogrel film-coated tablet formulations in healthy volunteers.

The present study was performed to compare the bioavailability of two clopidogrel 75 mg film-coated tablet formulations (test formulation and reference formulation). This study was a randomized, single-blind, two-period, two-sequence cross-over study which included 24 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters were assessed based on the concentrations of clopidogrel (CAS 120202-66-6) parent compound.

Bioequivalence study of two perindopril erbumine tablet formulations in healthy volunteers.

The present study was performed to compare the bioavailability of two perindopril erbumine (CAS 107133-36-8) 4 mg tablet formulations (test formulation and reference formulation). This study was a randomized, single-blind, two-period, two-sequence cross-over study which included 20 healthy adult male and female subjects under fasting conditions. In this study, one subject withdrew from the study and one reserve subject did not appear at both periods.

Bioequivalence study of two minocycline capsule formulations in healthy volunteers.

The bioequivalence of two capsule formulations containing 100 mg minocycline was assessed in 12 healthy adult male and female volunteers in a crossover, randomized, single-blind study. The participating volunteers were required to fast overnight and in the next morning and were given orally one capsule of the test drug (Acnez) or one capsule of the reference drug. Blood samples were drawn immediately before taking the drug (control), and at 0.

Bioequivalence study of two azithromycin formulations in healthy subjects.

The study was conducted to find out whether the bioavailability of a 500 mg azithromycin (CAS 83905-01-5) tablet (Zycin, test) was equivalent to that of a reference formulation. The pharmacokinetic parameters assessed in this study were the area under the plasma concentration-time curve from time zero to 120 h (AUCt), area under the plasma concentration-time curve from time zero to infinity (AUCinf), the peak plasma concentration of the drug (Cmax), time needed to achieve the peak plasma concentration (tmax), and the elimination half-life (t1/2). This was a randomized, single blind, two-period, cross-over study which included 18 healthy adult male and female subjects under fasting conditions.

Comparative bioavailability cf two amlodipine formulation in healthy volunteers.

The present study was conducted to find out whether the bioavailability of a 10 mg amlodipine (CAS 88150-42-9) tablet (Intervask, "test") was equivalent to that that of a reference formulation ("reference"). The pharmacokinetic parameters assessed in this study were area under the serum concentration-time curve from time zero to 144 h (AUCt), area under the serum concentration-time curve from time zero to infinity (AUCinf), the peak serum concentration of the drug (Cmax), time needed to achieve the peak serum concentration (tmax), and elimination half life (t(1/2)). This was a cross-over, randomized, single-blind study which included 12 healthy male and female volunteers under fasting condition.