Clinical trial NCT05849883: Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject
Official title: Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use
Keywords: Omeprazole
Bioequivalence Study
Lead sponsor: PT Kalbe Farma Tbk
Sponsor class: INDUSTRY
Collaborators: name: PT Pharma Metric Labs
First posted: 2023-05-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, single blind, single dose, 2-treatment, 3-sequence, 3-period partial replicate design study with one week washout period in 36 healthy subjects under fasting condition.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean Ratio of Cmax
timeFrame: 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
measure: Geometric Mean Ratio of AUCt
timeFrame: 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 outcomes:
measure: Pharmacokinetics Parameter of Cmax
timeFrame: 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
measure: Pharmacokinetics Parameter of AUCt
timeFrame: 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
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: PT Pharma Metric Labs
state: DKI Jakarta
Study officials:
affiliation: PT Pharma Metric Labs
name: Frans D Suyatna
role: PRINCIPAL_INVESTIGATOR
affiliation: PT Pharma Metric Labs
name: I Gusti Putu Bagus Diana Virgo
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: Oosterhuis B, Jonkman JH. Omeprazole: pharmacology, pharmacokinetics and interactions. Digestion. 1989;44 Suppl 1:9-17. doi: 10.1159/000200098.
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.