Bioequivalence study of Iranian drugs with brand drugs

Evaluation of pharmacokinetic parameters and in vitro bioequivalence study of generic desloratadine 5 mg tablets manufactured by Poorsina Pharmaceutical Company with brand drug in a cross-over and double-blind study in healthy Iranian volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231108059993N1

Enrollment

Registered

2024-07-09

Start date

2024-07-08

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Healthy volunteers.

Interventions

Intervention group: One group will take the domestic brand drug and the other group will take the foreign brand drug and after 4 weeks the used drug brand will be changed in the groups..

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: All volunteers should be non smoking. All volunteers should have generally (kidney, liver, respiratory system and neuropsychology) health. All volunteers should Informed consent.

Exclusion criteria

Exclusion criteria: Having special diseases. being smoker. Using drugs with contractions with des loratadine. Having liver and kidney diseases.

Design outcomes

Primary

Measure	Time frame
Drug blood concentration. Timepoint: 4 weeks. Method of measurement: HPLC.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Ghanbarzadeh

Daroo Shimi Teb Sanjesh Company

s_ghanbarzadeh@yahoo.com+98 41 3476 9144

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026