NCT05849883 is a NA clinical trial of Omeprazole 20 mg Capsules in Drug Use, sponsored by PT Kalbe Farma Tbk.

Who is sponsoring NCT05849883?

NCT05849883 is sponsored by PT Kalbe Farma Tbk.

What drugs are being tested in NCT05849883?

Interventions in NCT05849883: Omeprazole 20 mg Capsules.

Is NCT05849883 still recruiting?

NCT05849883 is currently completed. Last updated 9 May 2023.

Last reviewed 2023-05-09 · How we verify

NCT05849883

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Completed NA Last updated 9 May 2023

What this trial tests

NA trial testing Omeprazole 20 mg Capsules in Drug Use in 36 participants. Completed in 3 February 2021.

Timeline

10 December 2020

Primary endpoint
14 January 2021

3 February 2021

Quick facts

Lead sponsor	PT Kalbe Farma Tbk
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	36
Start date	10 December 2020
Primary completion	14 January 2021
Estimated completion	3 February 2021
Sites	1 location across Indonesia

Drugs / interventions tested

Omeprazole 20 mg Capsules — full drug profile →

Conditions studied

Drug Use — all drugs for Drug Use →

Sponsor

PT Kalbe Farma Tbk — full company profile →

Who can join

Adults 18 to 44, any sex, with Drug Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05849883 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PT Kalbe Farma Tbk
Last refreshed: 9 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05849883.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing