Bioequivalence Study of Two Oral-Capsule Formulations of Pregabalin 300 mg in Healthy Mexican Adult Volunteers

2016 ◽  
Author(s):  
Rosete-Reyes A ◽  
Mendoza-Tamayo G ◽  
López-Bojórquez E ◽  
Burke-Fraga V ◽  
González-de la Parra M
Keyword(s):  
Bioequivalence Study ◽  
Adult Volunteers ◽  
Oral Capsule

scholarly journals A Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers

2017 ◽  
Vol 34 (9) ◽  
pp. 2071-2082 ◽  
Author(s):  
Lin Pan ◽  
Paula Belloni ◽  
Han Ting Ding ◽  
Jianshuang Wang ◽  
Christopher M. Rubino ◽  
...  
Keyword(s):  
Healthy Adult ◽  
Bioequivalence Study ◽  
Dosage Forms ◽  
Adult Volunteers

scholarly journals Bioequivalence Study of 100-mg Cilostazol Tablets in Healthy Thai Adult Volunteers

2019 ◽  
Vol 91 ◽  
pp. 11-16
Author(s):  
Somruedee Chatsiricharoenkul ◽  
Yanisorn Nanchaipruek ◽  
Patcharaporn Manopinives ◽  
Suparat Atakulreka ◽  
Suvimol Niyomnaitham
Keyword(s):  
Bioequivalence Study ◽  
Adult Volunteers

scholarly journals 2229. Relative Bioavailability of a Single Oral Dose of SUBA-Itraconazole 65 mg Capsule Compared with Conventional Itraconazole 100 mg Capsule Administered Under Fasted and Fed Conditions in Healthy Adult Volunteers

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S761-S761
Author(s):  
Stuart Mudge ◽  
Phoebe Lewis ◽  
Bruce P Burnett
Keyword(s):  
Single Dose ◽  
Bioequivalence Study ◽  
Serum Levels ◽  
Relative Bioavailability ◽  
High Fat ◽  
Open Label ◽  
Post Dose ◽  
Geometric Means ◽  
Unique Nature ◽  
Adult Volunteers

Abstract Background Conventional itraconazole (CI) absorption from capsules even under fed conditions is suboptimal (~55%), let alone when fasted. SUBA-itraconazole (SI) is ~1.8x’s more bioavailable than CI at steady-state in a fed condition. There are, however, no data comparing these formulations under a fasted state. A single-dose PK study was performed comparing bioavailability of 65mg SI to 100mg CI under fasted or fed conditions. Methods This was an open-label, single-dose, randomized, four-period, four-treatment, four-sequence, crossover bioequivalence study under fasted and fed conditions in healthy adults. Subjects were administered a single dose of SI (1 × 65 mg) and CI (1 × 100 mg). Under fasted condition, subjects were administered SI or CI following an overnight fast of at least 10 hours. Subjects under fed condition were administered SI or CI after 30 minutes of consuming a standardized high fat breakfast preceded by an overnight fast of at least 10 hours. After dosing, all subjects fasted for at least 4 hours post-dose in all periods. Blood samples were collected prior to dosing and then from 1 to 120 hours. Analysis of itraconazole (IZ) and hydoxyitraconazole (HIZ) serum levels was by least-squares-geometric means of PK parameters. Results Under fasted condition, Cmax and AUCtau of IZ for SI were substantially higher compared with CI (Table, Figure 1). Under fed conditions, however, the Cmax and AUCtau of IZ for SI was 20% and 10% lower, respectively (table, Figure 2). Similar results were found for HIZ. The Tmax for IZ and HIZ of SI and CI were similar under a fasted condition but extended by over 2 hours for SI vs. CI under fed conditions. Study drugs were well-tolerated under fasted and fed conditions. All TEAEs were mild and resolved at the end of the study. Fifty of 52 subjects enrolled completed the study. Two subjects did not complete the study due to not being able to finish a high fat meal and noncompliance. No SAEs were reported. Conclusion Total and peak IZ/HIZ exposure was substantially higher for SI under fasted conditions compared with CI, but slightly lower under fed conditions with similar safety profiles. This study demonstrates the unique nature of the SI formulation compared with CI under fasted conditions and may lead to less variability if patients are not adherent to dietary requirements when taking itraconazole. Disclosures All authors: No reported disclosures.

scholarly journals Randomized, single-dose, two-period, two-sequence crossover bioequivalence study evaluating two oral formulations of lamotrigine in healthy volunteers

2021 ◽  
Vol 10 (6) ◽  
pp. 648
Author(s):  
Murgan Panchatcharam ◽  
Sasidharan M. ◽  
Sakthimanikandhan .
Keyword(s):  
Single Dose ◽  
Confidence Intervals ◽  
High Performance ◽  
Bioequivalence Study ◽  
Oral Formulations ◽  
Vital Functions ◽  
Healthy Adult Male ◽  
The Mean ◽  
Adult Volunteers ◽  
Lamotrigine Concentration

Background: Lamotrigine is an anti-epileptic medicine used to treat epilepsy and bipolar disorder. The mechanism of action is to block voltage activated sodium channels. The aim of this study was to evaluate the bioequivalence of 2 oral formulations of lamotrigine 25 mg in healthy volunteers.Methods: A single-dose, two-period, randomized crossover study design in - healthy Indian adult volunteers was conducted at Amaris Clinical, a division of Caplin Point Laboratories Ltd., Chennai. A validated high performance liquid chromatography in conjunction with mass spectrometry was used. Lamotrigine concentration in plasma. Adverse events were determined by measuring vital functions after dosing. A total of 24 subjects were included.Results: The mean and 90% confidence intervals of the test / reference ratios for these parameters were as follows: The mean Cmax and Tmax of the test were 758.606 (157.453) ng / ml and 1.17 (0.50-5.00) hours, respectively. The mean Cmax and Tmax of the reference were 775.993 (151.654) ng / ml or 0.88 (0.25-4.00) hours. The mean AUC0-72 was 24142. 031±3641.691 (ng.hr/mL) for the test formulation and 24202.099±3742.957 (ng. h / ml) for the reference formulation. The mean test / reference ratios for Cmax and AUC0-72 were 97.92 and 99.82 respectively. The 90% parametric CIs for Cmax and AUC0-72 were 90.17-105.68% or 97.87-101.81%.Conclusions: The 90% confidence intervals ranged from 80-125% and it was concluded that the test product was bioequivalent to the reference product in these healthy adult male volunteers. 

A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults

2017 ◽  
Vol 24 (3) ◽  
pp. 414-419 ◽  
Author(s):  
Carolyn Sikes ◽  
Jeffrey G. Stark ◽  
Russ McMahen ◽  
Dorothy Engelking
Keyword(s):  
Single Dose ◽  
Extended Release ◽  
Healthy Adult ◽  
Bioequivalence Study ◽  
Oral Suspension ◽  
Pharmacokinetic Parameters ◽  
Open Label ◽  
Adult Participants ◽  
Study Results ◽  
Adult Volunteers

Objective: The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. Method: In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for d- and l-amphetamine concentrations, and pharmacokinetic parameters Cmax, AUC0-5, AUC5-last, and AUCinf were calculated to determine bioequivalence. Safety was monitored throughout the study. Results: The 90% confidence intervals (CIs) for the log-transformed Cmax, AUC0-5, AUC5-last, and AUCinf fell within the accepted 80% to 125% range for establishing bioequivalence for d- and l-amphetamine. The most common adverse events were nausea and decreased appetite. Conclusion: AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.

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