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Drug UseNCT05849883

Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

A study testing Omeprazole 20 mg Capsules in people with Drug Use, run by PT Kalbe Farma Tbk at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 44 yearsHealthy volunteers can take part
Conditions the study is for
Drug Use
What is being tested?
Omeprazole 20 mg Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteIndonesia
Study dates
10 Dec 2020to 3 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • PT Pharma Metric Labs

    Jakarta Pusat, DKI Jakarta, 10520

Other trials in Indonesia

About this study

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.

Read the 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.

Conditions
Drug Use
Being tested
Omeprazole 20 mg Capsules
Keywords
Omeprazole, Bioequivalence Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omeprazole 20 mg CapsulesDrug

    Also called Losec® 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

Study groups in NCT05849883
Study groupRoleWhat they receive
Omeprazole 20 mg capsulesExperimentalSubjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water
Receives: Drug: Omeprazole 20 mg Capsules
Losec® 20 mg capsulesActive comparatorSubjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water
Receives: Drug: Omeprazole 20 mg Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Ratio of Cmax

    The ratio between maximum concentration of test drug and reference drug after drug administration

    Measured: 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

  2. Geometric Mean Ratio of AUCt

    The ratio between area under curve from 0 to 10 hours of test drug and reference drug

    Measured: 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)

  1. Pharmacokinetics Parameter of Cmax

    Maximum plasma concentration (Cmax)

    Measured: 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

  2. Pharmacokinetics Parameter of AUCt

    Area Under Curve from 0 to 10 hours (AUCt)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start10 Dec 2020
  3. Primary completion14 Jan 2021
  4. Study completion3 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05849883
Sponsor's protocol ID
551/STD/PML/2020
Status last verified
May 2023
First submitted
8 Feb 2023
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27615007

  • 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.

    PubMed 2690330

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

    PubMed 2691315

  • 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.

    PubMed 28618191

Questions about this trial

What is this clinical trial studying?

A study testing Omeprazole 20 mg Capsules in people with Drug Use, run by PT Kalbe Farma Tbk at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Ratio of Cmax (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05849883, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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