Dustri Online Services

Search Results

Books: 0	Journals: 1	Articles: 2

Bioavailability Section

A bioequivalence study of two omeprazole formulations in healthy male volunteers

Yu Kyong Kim, Seonghae Yoon, Kyung-Sang Yu, Bo-Hyung Kim, and Sung-Vin Yim

Price
42.00 $

Add to Cart

Price

42.00 $

Volume 54 p. 928 - 934

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 11/2016 (928-934)

A bioequivalence study of two omeprazole formulations in healthy male volunteers

Yu Kyong Kim¹, Seonghae Yoon¹, Kyung-Sang Yu¹, Bo-Hyung Kim², and Sung-Vin Yim²

¹Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, and ²Department of Clinical Pharmacology and Therapeutics, Kyung Hee University College of Medicine and Hospital, Seoul, Korea
Objective: This study had a single-dose, randomized, open-label, 2-period, and 2-sequence crossover design to evaluate pharmacokinetic (PK) bioequivalence between the test and reference formulations. Methods and materials: Of the 34 healthy male volunteers enrolled, 4 were excluded owing to consent withdrawal before drug administration and the remaining 30 subjects were administered 20 mg each of the test and reference formulations of omeprazole. The blood samples for PK analysis were collected at the scheduled time-points, prior to dosing to 10 hours after dosing. Plasma concentrations of omeprazole were quantified by a liquid chromatography-tandem mass spectrometry method. Bioequivalence was assessed according to current guidelines issued by regulatory authorities. Results: The plasma concentration-time profiles of omeprazole were similar between the reference and test drugs. The geometric mean ratios (90% confidence interval: CI) of test to reference were 0.9104 (0.8538 – 0.9708) for peak plasma concentration (C_max) and 0.9304 (0.8836 – 0.9796) for area under the plasma concentration-time curve from time zero to time of last measureable concentration (AUC_0–t). Conclusion: The results from the PK analysis suggested that the reference and test formulations of 20 mg omeprazole capsules were bioequivalent in healthy male subjects.Correspondence to:
Sung-Vin Yim, MD, PhD
Department of Clinical Pharmacology and Therapeutics
Kyung Hee University College of Medicine and Hospital
23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea
Email: [email protected]

Original

Comparison of the acid suppression effects between low-dose esomeprazole and famotidine in healthy subjects 

Ha-Yeon Kim, Jun Gi Hwang, Jae-Won Kim, Chang Hwan Seong, Ji Hyeon Lee, Young-sim Choi, Hyo Jin Min, Hyung Son Kim, Hye Yun Kim, Yu Kyong Kim, and Min Kyu Park

Price
42.00 $

Add to Cart

Price

42.00 $

Volume 61 (2023) p. 377 - 385

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 61 – No. 9/2023 (377-385)

Comparison of the acid suppression effects between low-dose esomeprazole and famotidine in healthy subjects 

Ha-Yeon Kim¹*, Jun Gi Hwang¹*, Jae-Won Kim¹, Chang Hwan Seong¹, Ji Hyeon Lee¹, Young-sim Choi¹, Hyo Jin Min¹, Hyung Son Kim²#³, Hye Yun Kim², Yu Kyong Kim¹, and Min Kyu Park¹

¹Department of Clinical Pharmacology and Therapeutics, Chung-buk National University Hospital, Cheong-ju, ²Daewon Pharmaceutical Co., Ltd., Seoul, and ³Kyung Hee University, Seoul, Republic of Korea
Objective: Famotidine, an H₂ receptor antagonist (H₂RA), is mainly prescribed to alleviate the early symptoms of gastritis. Our aim was to explore the possibilities of low-dose esomeprazole as a treatment of gastritis as well as the pharmacodynamic (PD) properties of esomeprazole and famotidine.
Materials and methods: A randomized, multiple-dose, 6-sequence, 3-period crossover study was conducted with a 7-day washout between periods. For each period, the subjects were administered one dose of esomeprazole 10 mg or famotidine 20 mg or esomeprazole 20 mg each day. To evaluate the PDs, the 24-hour gastric pH was recorded after single and multiple doses. The mean percentage of time during which the gastric pH was above 4 was evaluated for PD assessment. To confirm the pharmacokinetic (PK) characteristics of esomeprazole, blood was collected for up to 24 hours after multiple doses.
Results: 26 subjects completed the study. Following the multiple doses of esomeprazole 10 mg, esomeprazole 20 mg, and famotidine 20 mg, the mean percentages of time during which the gastric pH was above 4 over the course of 24 hour were 35.77 ± 19.56%, 53.75 ± 20.55%, and 24.48 ± 17.36%, respectively. After multiple doses, the time of peak plasma concentration at steady state (t_max,ss) was 1.00 and 1.25 hours for 10 and 20 mg of esomeprazole, respectively. The geometric mean ratio and its 90% confidence interval of area under the plasma drug concentration-time curve in steady state (AUC_T,ss) and maximum concentration of drug in plasma in steady state (C_max,ss) for esomeprazole 10 mg compared to 20 mg were 0.3654 (0.3381 – 0.3948) and 0.5066 (0.4601 – 0.5579), respectively.
Conclusion: The PD parameters of esomeprazole 10 mg were comparable to those of famotidine after multiple doses. These findings provide support for further evaluating the use of 10 mg of esomeprazole as a treatment option for gastritis.

*H.Y. Kim and J.G. Hwang contributed equally to this manuscriptCorrespondence to:
Min Kyu Park, MD, PhD
Department of Clinical Pharmacology and Therapeutics
Chung-buk National University Hospital
776, 1sunhwan-ro, Seowon-gu,
Cheongju-si, Chungcheongbuk-do, 28644
Republic of Korea
Email: [email protected]

Shopping Overview

Shopping Overview
Type	Qtty	Discount	VAT	Price
Your basket is empty

View Cart

Search Results

Shopping Overview

Send us an E-Mail