Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Drug Use Clinical Trial

Official title:

Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05849883
• Other study ID #: 551/STD/PML/2020
• Status: Completed
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: February 3, 2021

Study information

• Verified date: May 2023
• Source: PT Kalbe Farma Tbk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was conducted to investigate whether 20 mg omeprazole capsules manufactured by PT. Dankos Farma for PT. Hexpharm Jaya is bioequivalent to its reference product, 20 mg Losec® capsules manufactured by AstraZeneca AB, Sweden, imported by PT. AstraZeneca Indonesia.

Description:

Thirty six healthy subjects were given a single dose of 20 mg omeprazole capsules or 20 mg Losec® capsules with 240 mL of water. Then the blood samples for omeprazole were drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 3, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

The inclusion criteria were healthy male or female subjects who/with:

• had read the subject information and signed informed consent documents
• age range from 18 - 55 years
• body mass index between 18-25 kg/m2
• had a normal electrocardiogram
• had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
• had the heart rate within normal range (60 - 100 bpm)
• had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.
• accepted to use protection (condom) before any intercourse with their spouse throughout the study

Excluded from the study were:

• those who were pregnant and/or nursing women (for women).
• those with history of contraindication or hypersensitivity to omeprazole, or other proton pump inhibitor drugs or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction.
• those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
• those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
• those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day.
• those who had participated in any clinical study within 3 months prior to the study (<90 days).
• those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study.
• those who smoked more than 10 cigarettes a day
• those who were reactive to SARS CoV-2 test.
• those with a history of travelling to another city within the last 14 days
• those with a history of direct contact with a COVID-19 positive person in the subject's neighborhood
• those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days
• those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
• those with a history of drug or alcohol abuse within 12 months prior to screening for this study.
• those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.

Related Conditions & MeSH terms

• Drug Use

Intervention

Drug:
• Omeprazole 20 mg Capsules
Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production

Locations

Country	Name	City	State
Indonesia	PT Pharma Metric Labs	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
PT Kalbe Farma Tbk	PT Pharma Metric Labs

Country where clinical trial is conducted

Indonesia, 

References & Publications (4)

Cederberg C, Andersson T, Skanberg I. Omeprazole: pharmacokinetics and metabolism in man. Scand J Gastroenterol Suppl. 1989;166:33-40; discussion 41-2. doi: 10.3109/00365528909091241. — View Citation

Dubcenco E, Beers-Block PM, Kim LP, Schotland P, Levine JG, McCloskey CA, Bashaw ED. A Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long-Term Safety. Clin Transl Sci. 2017 Sep;10(5):387-394. doi: 10.1111/cts.12475. Epub 2017 Jun 15. — View Citation

Kim YK, Yoon S, Yu KS, Kim BH, Yim SV. A bioequivalence study of two omeprazole formulations in healthy male volunteers. Int J Clin Pharmacol Ther. 2016 Nov;54(11):928-934. doi: 10.5414/CP202580. — View Citation

Oosterhuis B, Jonkman JH. Omeprazole: pharmacology, pharmacokinetics and interactions. Digestion. 1989;44 Suppl 1:9-17. doi: 10.1159/000200098. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Ratio of Cmax	The ratio between maximum concentration of test drug and reference drug after drug administration	before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration
Primary	Geometric Mean Ratio of AUCt	The ratio between area under curve from 0 to 10 hours of test drug and reference drug	before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration
Secondary	Pharmacokinetics Parameter of Cmax	Maximum plasma concentration (Cmax)	before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration
Secondary	Pharmacokinetics Parameter of AUCt	Area Under Curve from 0 to 10 hours (AUCt)	before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration

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