Comparison between 200 mg generic celecoxib hard capsules and Celebra®: bioequivalence study in healthy male and female subjects under fasting conditions after a single dose

ABSTRACT

BACKGROUND AND OBJECTIVES:

The objective of this study was to assess the bioequivalence between two 200 mg celecoxib hard capsule formulations administered to healthy male and female participants under fasting conditions with the aim of providing an alternative pharmaceutical product to the reference drug, Celebra®.

METHODS:

A randomized, open label, single dose, 2x2 crossover trial was conducted with 60 adult healthy subjects under fasting conditions comparing single doses of two celecoxib hard capsules formulation. Pharmacokinetic parameters were calculated following the determination of drugs concentrations in human plasma using a validated liquid chromatography with a tandem mass spectrometer detector method (LC-MS/MS).

RESULTS:

Statistical analysis provided geometric mean of test/reference ratio, confidence intervals, intra-subject variation coefficient and power of the test to the pharmacokinetic parameters C_max, AUC_0-t, and AUC_0-∞. Confidence intervals for the geometric mean (90% CI) of the test/reference drugs for celecoxib were 98.26 to 122.75% for C_max, 100.27% to 110.78% for AUC_0-t, and 96.87% to 110.29% for AUC_0-∞. The power of the test found was 95.09% for C_max, 100.00% for AUC_0-t, and 99.99% for AUC_0-∞.

CONCLUSION:

The formulations met the Brazilian standards for interchangeability, as the confidence intervals for C_max and AUC_0-t ratios are within the range of 80% to 125%, thus meeting the requirements of the legislation during market registration. The researched product was approved by the regulatory authorities and became a commercially competitive option to the reference product for the Brazilian population.

Keywords:
Analgesics; Arthritis; Bioequivalence; Celecoxib; COX-2; Osteoarthritis rheumatoid

HIGHLIGHTS

Celecoxib is one of the few COX-2 inhibitors anti-inflamatory currently in use in Brazil.

The study was conducted with a 2x2 crossover design with 60 healthy adult subjects, comparing generic Celecoxib 200 mg hard capsules with Celebra®.

The study demonstrated that the generic test drug has a pharmacokinetic profile equivalent to that of the reference drug and meets the criteria for bioequivalence based on Cmax and AUC, thus concluding that the formulations are interchangeable.