Bioequivalence Study of desloratadine 5 mg manufactured by Pharma Chemi and Clarinex manufactured by Schering

Bioequivalence Study of desloratadine 5 mg manufactured by Pharma Chemi and Clarinex manufactured by Schering in 24 Healthy Volunteers under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220209053979N7

Enrollment

Registered

2023-04-29

Start date

2023-04-21

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

A crossover bioequivalence study in 24 healthy volunteers.

Interventions

Intervention 1: Intervention group: 1: Oral administration of two tablets of desloratadine 5 mg manufactured by Pharmachemi/ Schering Company to 12 healthy volunteers under fasting condition with 240

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy male or female volunteers between the age of 18 and 55 with a body mass index (BMI) between 19 and 30 volunteers who are willing to sign an informed consent form

Exclusion criteria

Exclusion criteria: History of allergy to desloratadine or formulation components History or significant clinical evidence of any disease Taking any type of medicine in the 14 days before the start of the study Participation in any clinical study within 30 days prior to study initiation

Design outcomes

Primary

Measure	Time frame
Plasma concentration time profile, maximum plasma concentration, AUC. Timepoint: 0, 0,5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24, 48, 72 hours after drug administration. Method of measurement: Liquid chromatography with mass spectrophotometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Talari

Kharazmi Plasma Center

talari_r@yahoo.com+98 21 5669 4726

Outcome results

None listed

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