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Bioequivalence Study of Trientine 250 mg tablets

Evaluation of Pharmacokinetic Parameters and in Vivo Bioequivalence Study of Trientine 250 mg tablets Manufactured by ?Daroo Darman Arang Pharmaceutical Company with brand drug healthy Iranian volunteers.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231108059993N7
Enrollment
24
Registered
2025-10-17
Start date
2025-11-11
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Healthy volunteers.

Interventions

Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of the Trentine 250 mg tablets manufactured by Daroo Darman Arang Pharmaceutical Company. In each period, 1

Sponsors

Arang Daroo Darman Company
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Having general health (liver, heart, and kidneys) Having a body mass index (18-28) Informed consent will be obtained. The age of the volunteers will be in the range if (18-60 years). No history of allergy to trientine

Exclusion criteria

Exclusion criteria: History of allergic or adverse reaction to Trientine or any similar product Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg Individuals who have donated whole blood during the last 2 months from the study Individuals who have donated blood components within 2 weeks before taking the first dose of the drug.

Design outcomes

Primary

MeasureTime frame
Plasma Concentration. Timepoint: 13 sampling times included pre-dose (time 0) and at the following hours post-dose: 0.5,1,1,5, 2, 3, 4, 6, 8, 12, 24, 48, 72 Hours. Method of measurement: Liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Ghanbarzadeh

Tabriz Univesity of Medical Science

s_ghanbarzadeh@yahoo.com+98 41 3383 2649

Outcome results

None listed

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