Bioequivalance study of Tramadole 100 mg Tablets

Bioequivalance study of Tramadole 100 mg Tablets manufactured by Shahr Daru pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Reference Tablets

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200513047423N7

Enrollment

Registered

2022-04-06

Start date

2022-05-27

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Bioequivalance Tramadole 100 mg.

Interventions

Intervention group: One Tramadole 100 mg tablet manufactured by Shahr daru company (Test drug) is administrated to each of 12 healthy volunteer of group 1.

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy liver Healthy kidney Volunteers should not be too fat or too thin and their weight index should be in the appropriate range

Exclusion criteria

Exclusion criteria: Out of age ranges smoking pregnancy

Design outcomes

Primary

Measure	Time frame
Plasma concentration changing after administration of Tramadole 100 mg tablet.Plasma concentration of Tramadole at Tmax reaches about 350 ng/mL and its measurement range is from 10ng / mL to 1000ng / mL. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each volunteers. Hence the Tmax of Tramadole is between 1 and 2 hours, so it is needed to have 5 blood sampling before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. Method of measurement: In this study, the variable is plasma concentration of Tramadole. High performance liquid chromatography is used to determine the concentration of Tramadole in plasma.	—

Measure

Time frame

Plasma concentration changing after administration of Tramadole 100 mg tablet.Plasma concentration of Tramadole at Tmax reaches about 350 ng/mL and its measurement range is from 10ng / mL to 1000ng / mL. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each volunteers. Hence the Tmax of Tramadole is between 1 and 2 hours, so it is needed to have 5 blood sampling before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. Method of measurement: In this study, the variable is plasma concentration of Tramadole. High performance liquid chromatography is used to determine the concentration of Tramadole in plasma.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir mehdizadeh

Ofoqh pharmed labratory

Ofoghfarmed.lab@gmail.com+98 21 6673 8727

Outcome results

None listed

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