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Bioequivalence study of Tenefovir alafenomide

Bioequivalence evaluation of Tenefovir alafenomide 25 mg tablet manufactured by the Fan Avaran Rojan Mohaghegh Darou and the Vemlidy 25 mg tablet manufactured by the Gilead pharmaceutical companies in healthy human volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110523006565N5
Enrollment
24
Registered
2025-01-28
Start date
2025-02-14
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Bioequivalence study.

Interventions

Intervention group: Prescription of?Tenefovir ,25 mg Tablet manufactured by Fanavaran Rijan mohaghegh and Gilead pharmaceutical companies f.

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 44 Years

Inclusion criteria

Inclusion criteria: Written informed consent. Normal findings in the physical examination. Clinical laboratory values within 10% above or below the laboratory’s stated normal range To be a non-smoker

Exclusion criteria

Exclusion criteria: History of hypersensitivity to the study drug or related products Significant history or presence of gastrointestinal, liver or kidney disease, or any other condition known to interfere with the pharmacokinetics of the drug Any clinically significant illness during the 4 weeks prior to day 1 of this study Maintenance therapy with any drug, or history of drug dependence Alcohol abuse, or serious neurological or psychological disease Use of any systemic medication (including OTC preparations) within 14 days preceding day 1 of this study Positive test of HIV and Hepatitis A, B and C

Design outcomes

Primary

MeasureTime frame
Plasma concentrations. Timepoint: 0 , 0.2 , 0.4, 1 2 , 1.5 , , 2.5 , 3 3.5 , , 4 , 4.5 5, 6 , 8 , 12 , 24 48. Method of measurement: High resolution Lc-mass mass.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamreza Bahrami

Kermanshah University of Medical Sciences

gbahrami@kums.ac.ir+98 83 3428 1562

Outcome results

None listed

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