Bioequivalence study of dydrogesterone 10 mg tablet

Bioequivalence study of dydrogesterone 10 mg tablet of Ati Pharmed pharmaceutical company compared to dydrogesterone 10 mg sample of Abbott Biologicals B.V. The Netherlands on a healthy volunteer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N2

Enrollment

Registered

2023-03-14

Start date

2023-04-04

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

In the present study, no disease was investigated..

Interventions

Intervention group: The study consists of two phases (taking a dydrogesterone 10 mg tablet orally at each study for a total of 2 times) with a two-week washout period (when the drug is completely out

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Healthy non-pregnant and non-lactating volunteer Female volunteer aged between 18 to 45 years old The body mass index (BMI) less than 30 kg/m2 All of the volunteers should be non-smoker.

Exclusion criteria

Exclusion criteria: Blood pressure lower than 90/60 mm Hg or higher than 140/90 mm Hg, Smokers who use more than 10 cigarettes a day Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentration of dydrogesterone. Timepoint: 5 ml of blood taken from you before taking the drug and at time intervals: 0, 0.25, 0.75, 0.5, , 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours after administration (15 times in total). Method of measurement: HPLC chromatography with copper copper detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jalalipour

Nik Azma Pars Alborz laboratory

info@naplab.ir+98 26 3731 8748

Outcome results

None listed

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