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In-vivo Bioequivalence Study of Valganciclovir 450 mg Tablets of The Test Drug (Actoverco Pharmaceutical Company)

In-vivo Bioequivalence Study of Valganciclovir 450 mg Tablets of The Test Drug (Actoverco Pharmaceutical Company) Compared with The Reference Drug (Roche Company, Germany) In Iranian Healthy Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240804062647N5
Enrollment
24
Registered
2025-07-02
Start date
2025-07-23
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

This study is performed on healthy volunteers..

Interventions

Intervention 1: Intervention group: Single-dose of Valganciclovir 450 mg Tablets of The Test Drug (Actoverco Pharmaceutical Company), in the first period. Cross-over design with one week washing perio

Sponsors

?Actoverco Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health (liver, heart, kidney) of volunteers Body mass index range (18-30) Informed consent form Age between18-55

Exclusion criteria

Exclusion criteria: Smoking Pregnancy Having a hypersensitivity to the drug Having a Alcohol & Drug addiction Blood donation within the last 6 months

Design outcomes

Primary

MeasureTime frame
The concentration of the drug in blood. Timepoint: 0-0.33-0.66-1-1.33-1.66-2-2.5-3-3.5-4-5-6-8-24 h after drug administration. Method of measurement: Liquid Chromatography with Mass-Mass Detector.

Secondary

MeasureTime frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMassoud Amanlou

Tehran University of Medical Sciences

amanlou@tums.ac.ir+98 21 6695 9067

Outcome results

None listed

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