Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

NCT05849883 | Completed

• 1 other identifier: 551/STD/PML/2020
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Use

Keywords

Omeprazole; Bioequivalence Study

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Pharmacokinetics Parameter of 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

• Pharmacokinetics Parameter of 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

Study Arms (2)

Omeprazole 20 mg capsules

EXPERIMENTAL

Subjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water

Drug: Omeprazole 20 mg Capsules

Losec® 20 mg capsules

ACTIVE COMPARATOR

Subjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water

Drug: Omeprazole 20 mg Capsules

Interventions

Omeprazole 20 mg Capsules DRUG

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

Also known as: Losec® 20 mg capsules

Losec® 20 mg capsules; Omeprazole 20 mg capsules

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

Sponsors & Collaborators

• PT Kalbe Farma Tbk: lead
• PT Pharma Metric Labs: collaborator

Study Sites (1)

PT Pharma Metric Labs

Jakarta Pusat, DKI Jakarta, 10520, Indonesia

Location

Related Publications (4)

• 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.

  PMID: 27615007 BACKGROUND

• 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.

  PMID: 2690330 BACKGROUND

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

  PMID: 2691315 BACKGROUND

• 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.

  PMID: 28618191 BACKGROUND

Related Links

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MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Frans D Suyatna

  PT Pharma Metric Labs

  PRINCIPAL INVESTIGATOR

• I Gusti Putu Bagus Diana Virgo

  PT Pharma Metric Labs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: May 9, 2023
• Study Start: December 10, 2020
• Primary Completion: January 14, 2021
• Study Completion: February 3, 2021
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

ID (1)