In-vivo Bioequivalence Test of Tramadol® tablet with brand drugs (ULTRAM® 100mg, Junssen Cilage, Switzerland).

Pharmacokinetic assessments of Tramadol® tablet with brand drugs ULTRAM® 100mg Junssen Cilage, Switzerland

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N23

Enrollment

Registered

2021-02-08

Start date

2021-02-28

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

In this study, the disease is not examined. Subject bioequivalence test and reference tablets Tramadol studied..

Interventions

Intervention 1: Intervention group: Intervention group received one test drug table(Tramadol tablet 100mg Zagross Darou Pharmaceutical Company). Blood samples were taken from the volunteers for 72 hou

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body mass index(18-28) Informed consent Age(18-60)

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Determination of blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours After prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

Shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

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