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Related Concept Videos

Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
Modified-Release Drug Delivery Systems: Bioavailability01:30

Modified-Release Drug Delivery Systems: Bioavailability

Modified-release (MR) dosage forms are designed to extend drug release over time, thereby maintaining stable plasma concentrations and reducing dosing frequency. However, their bioavailability is typically below 100% due to incomplete drug release and presystemic metabolism, and limitations in drug permeability across the gastrointestinal epithelium, all of which can restrict the fraction of the drug reaching systemic circulation. Consequently, studying the in vivo bioavailability of MR...
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
Bioavailability Study Design: Absolute Versus Relative Bioavailability01:27

Bioavailability Study Design: Absolute Versus Relative Bioavailability

Bioavailability is a crucial pharmacokinetic parameter that quantifies the proportion of an administered drug that reaches the systemic circulation and is available for therapeutic action. Regulatory agencies mandate the assessment of bioavailability, typically measured as the area under the drug plasma concentration-versus-time curve (AUC), to ensure the efficacy and safety of pharmaceutical products. These evaluations are categorized as absolute and relative bioavailability studies.Absolute...
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...

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Related Experiment Video

Updated: Jul 3, 2026

Methods for the Discovery of Novel Compounds Modulating a Gamma-Aminobutyric Acid Receptor Type A Neurotransmission
07:16

Methods for the Discovery of Novel Compounds Modulating a Gamma-Aminobutyric Acid Receptor Type A Neurotransmission

Published on: August 16, 2018

Gabapentin Extended Release Tablets in Healthy Subjects Under Fed Conditions: A Randomized, Open-Label,

Sudershan Kumar1, Arshad Khuroo1, Sanjay Jagannath Gurule1

  • 1Clinical Pharmacology and Pharmacokinetics, Sun Pharmaceutical Industries Limited, Gurgaon, India.

Drugs in R&D
|July 1, 2026
PubMed
Summary
This summary is machine-generated.

Gabantin® GRS 600mg ER tablets demonstrated bioequivalence to Gralise® in healthy adults. This study confirms a comparable pharmacokinetic profile and good safety for the Gabapentin ER formulation.

Related Experiment Videos

Last Updated: Jul 3, 2026

Methods for the Discovery of Novel Compounds Modulating a Gamma-Aminobutyric Acid Receptor Type A Neurotransmission
07:16

Methods for the Discovery of Novel Compounds Modulating a Gamma-Aminobutyric Acid Receptor Type A Neurotransmission

Published on: August 16, 2018

Area of Science:

  • Pharmacology
  • Clinical Pharmacy
  • Drug Development

Background:

  • Gabapentin is a key anticonvulsant and analgesic, effective for neuropathic pain and post-herpetic neuralgia.
  • Available in immediate-release (IR) and extended-release (ER) formulations, gabapentin's therapeutic efficacy relies on its pharmacokinetic profile.
  • Understanding the comparative bioavailability of different gabapentin formulations is crucial for therapeutic interchange and patient management.

Purpose of the Study:

  • To assess the comparative bioavailability of Gabantin® GRS (Gabapentin ER 600 mg) versus Gralise® (Gabapentin 600 mg) under fed conditions.
  • To establish bioequivalence between the test (Gabantin® GRS) and reference (Gralise®) gabapentin extended-release formulations.
  • To evaluate the safety and tolerability of Gabantin® GRS in healthy adult subjects.

Main Methods:

  • An open-label, randomized, balanced, crossover study design was employed.
  • Healthy male adults received a single 600 mg dose of either Gabantin® GRS (Test) or Gralise® (Reference) in two periods, separated by a 12-day washout.
  • Key pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞) and adverse events were assessed.

Main Results:

  • The study enrolled and completed by 24 healthy subjects.
  • Gabantin® GRS exhibited a pharmacokinetic profile comparable to Gralise®, meeting bioequivalence criteria (0.80-1.25).
  • Specific ratios for AUC0-t (0.9171), AUC0-∞ (0.9191), and Cmax (0.9135) confirmed bioequivalence, with 90% CIs within the acceptable range. One instance of fever was reported as an adverse event.

Conclusions:

  • Gabantin® GRS 600 mg ER OD demonstrated bioequivalence to Gralise® in healthy subjects under fed conditions.
  • The pharmacokinetic profiles of both gabapentin formulations were found to be similar.
  • Gabantin® GRS exhibited a favorable safety and tolerability profile.