Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
NCT ID: NCT04198948
Last Updated: 2021-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2019-03-04
2019-08-05
Brief Summary
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A randomised, placebo-controlled, two-sequence, two-period crossover study will be performed to explore whether gliclazide pharmacokinetics (PK) and pharmacodynamics (PD) are altered upon co-administration with omeprazole. Sixteen healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers (EM/UM), will receive placebo or omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. Plasma concentration of gliclazide will be measured for 24 hours, and plasma glucose and insulin levels up to 12 hours after gliclazide administration.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Omeprazole, Then Placebo
Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive placebo under same conditions in a cross-over manner.
Omeprazole
Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Placebo oral tablet
Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Gliclazide
Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
Placebo, Then Omeprazole
Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive omeprazole under same conditions in a cross-over manner.
Omeprazole
Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Placebo oral tablet
Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Gliclazide
Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
Interventions
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Omeprazole
Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Placebo oral tablet
Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Gliclazide
Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
Eligibility Criteria
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Inclusion Criteria
* Age 18-30 years
* Non-smokers
* CYP2C19 extensive/ultrarapid metabolisers
Exclusion Criteria
* abnormalities in physical examination, ECG and routine clinical laboratory tests (including fasting blood glucose concentration)
* medication use during the 14 days prior and during the study period
* grapefruit, grapefruit juice, alcohol, beverages or food containing methylxanthines use during 72 h prior and during the study period
18 Years
30 Years
MALE
Yes
Sponsors
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General Hospital Prim. Dr. Abdulah Nakas
OTHER
University of Dundee
OTHER
Wellcome Trust
OTHER
University of Sarajevo
OTHER
Responsible Party
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Tanja Dujic, PhD
Associate Professor
Principal Investigators
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Tanja Dujic, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sarajevo
Aida Kulo Cesic, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sarajevo
Locations
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General Hospital Prim. Dr. Abdulah Nakas
Sarajevo, , Bosnia and Herzegovina
Countries
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References
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Kalra S, Aamir AH, Raza A, Das AK, Azad Khan AK, Shrestha D, Qureshi MF, Md Fariduddin, Pathan MF, Jawad F, Bhattarai J, Tandon N, Somasundaram N, Katulanda P, Sahay R, Dhungel S, Bajaj S, Chowdhury S, Ghosh S, Madhu SV, Ahmed T, Bulughapitiya U. Place of sulfonylureas in the management of type 2 diabetes mellitus in South Asia: A consensus statement. Indian J Endocrinol Metab. 2015 Sep-Oct;19(5):577-96. doi: 10.4103/2230-8210.163171.
Schopman JE, Simon AC, Hoefnagel SJ, Hoekstra JB, Scholten RJ, Holleman F. The incidence of mild and severe hypoglycaemia in patients with type 2 diabetes mellitus treated with sulfonylureas: a systematic review and meta-analysis. Diabetes Metab Res Rev. 2014 Jan;30(1):11-22. doi: 10.1002/dmrr.2470.
Zhang Y, Si D, Chen X, Lin N, Guo Y, Zhou H, Zhong D. Influence of CYP2C9 and CYP2C19 genetic polymorphisms on pharmacokinetics of gliclazide MR in Chinese subjects. Br J Clin Pharmacol. 2007 Jul;64(1):67-74. doi: 10.1111/j.1365-2125.2007.02846.x. Epub 2007 Feb 12.
Shao H, Ren XM, Liu NF, Chen GM, Li WL, Zhai ZH, Wang DW. Influence of CYP2C9 and CYP2C19 genetic polymorphisms on pharmacokinetics and pharmacodynamics of gliclazide in healthy Chinese Han volunteers. J Clin Pharm Ther. 2010 Jun;35(3):351-60. doi: 10.1111/j.1365-2710.2009.01134.x.
Sun XM, Tan JC, Zhu Y, Lin L. Association between diabetes mellitus and gastroesophageal reflux disease: A meta-analysis. World J Gastroenterol. 2015 Mar 14;21(10):3085-92. doi: 10.3748/wjg.v21.i10.3085.
Furuta T, Iwaki T, Umemura K. Influences of different proton pump inhibitors on the anti-platelet function of clopidogrel in relation to CYP2C19 genotypes. Br J Clin Pharmacol. 2010 Sep;70(3):383-92. doi: 10.1111/j.1365-2125.2010.03717.x.
Dujic T, Zhou K, Donnelly LA, Leese G, Palmer CNA, Pearson ER. Interaction between variants in the CYP2C9 and POR genes and the risk of sulfonylurea-induced hypoglycaemia: A GoDARTS Study. Diabetes Obes Metab. 2018 Jan;20(1):211-214. doi: 10.1111/dom.13046. Epub 2017 Aug 25.
Wedemeyer RS, Blume H. Pharmacokinetic drug interaction profiles of proton pump inhibitors: an update. Drug Saf. 2014 Apr;37(4):201-11. doi: 10.1007/s40264-014-0144-0.
Semiz S, Dujic T, Ostanek B, Prnjavorac B, Bego T, Malenica M, Marc J, Causevic A. Analysis of CYP2C9*2, CYP2C19*2, and CYP2D6*4 polymorphisms in patients with type 2 diabetes mellitus. Bosn J Basic Med Sci. 2010 Nov;10(4):287-91. doi: 10.17305/bjbms.2010.2662.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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209943/Z/17/Z
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0101-3678/18
Identifier Type: -
Identifier Source: org_study_id
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