Comparative Bioequivalence Study of the Naproxen 500 mg Enteric Coated Tablet

Comparative Bioequivalence Study of the Naproxen 500 mg Enteric Coated Tablet Manufactured by Loghman Pharmaceutical Company by Innovative Company

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231108059993N17

Enrollment

Registered

2026-05-10

Start date

2026-02-20

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers were enrolled in the study..

Interventions

Intervention group: The first intervention group, which has been randomly and double-blindly selected, will take the Iranian Naproxen tablets, and the second group will take a brand drug . After a 1-

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Good general health (liver, heart, and kidneys). Body mass index (18-28). Informed consent Ages range (18-60 years).

Exclusion criteria

Exclusion criteria: Addiction to alcohol, drugs and cigarettes Allergy to Naproxen Chronic disease treatment history

Design outcomes

Primary

Measure	Time frame
Drug Plasma Concentration. Timepoint: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 10, 12, 24, 48, 72 hour. Method of measurement: Liquid chromatography with dual mass spectrometer (LC/M?S/MS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Ghanbarzadeh

Tabriz University of Medical Sciences

s_ghanbarzadeh@yahoo.com0413832649

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026