Bioequivalence study of two Doxycycline Hyclate Enteric coated 100 mg capsule manufactured byTadbir kalaye jam company

Bioequivalence study of two Doxycycline Hyclate Enteric coated 100 mg capsule manufactured byTadbir kalaye jam company in comparison with DORYX® 100 mg Enteric coated capsule manufactured by Mayne Pharma in healthy volunteer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240803062623N11

Enrollment

Registered

2025-02-05

Start date

2025-05-22

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

In this study the , the disease is not investigated , bioequivalence of test and brand drug will be evaluated..

Interventions

Intervention 1: Intervention group: Single-dose of the test drug Doxycycline Hyclate Enteric coated 100 mg capsulemanufactured by tadbir kalaye jam company. Intervention 2: Control group: Single-dose

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: 0, 0.5 , 1 , 1.5 , 2 , 2.5 , 3 , 3.5 , 4 , 6 , 8 , 12 , 24 , 48 , 72h after drug adminstration. Method of measurement: HPLC-MS/MS.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma 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 ContactMohammad Ali Karkhaneh Yousefi

Tadbir Kalaye Jam co.

yousefi@tadbirkala.com+98 21 8866 8700

Outcome results

None listed

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