Bioequivalence study of empagliflozin 10 mg tablet

The bioequivalence study of empagliflozin 10 mg tablets of Daram Yab Darou pharmaceutical company compared to the sample of empagliflozin 10 mg manufactured by Boehringer Ingelheim and Eli Lilly, Germany, on healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N3

Enrollment

Registered

2023-04-03

Start date

2023-04-04

Completion date

Unknown

Last updated

2023-05-01

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

The study consists of two phases (taking one empegliflozin 10 mg tablet orally at each study time, for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Be between 18 and 50 years old. All candidates must be non-smokers. The Volunteer's body mass index (BMI) should be less than 30 kg for the square of their height in meters.

Exclusion criteria

Exclusion criteria: Volunteers with blood pressure less than 90/60 mm Hg or higher than 140/90 mm Hg. Volunteers should refrain from smoking, consuming alcohol, caffeine (including coffee, cocoa, tea, cola drinks) 48 hours before the start of the study.

Design outcomes

Primary

Measure	Time frame
Empagliflozin plasma concentrations. Timepoint: 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours. Method of measurement: HPLC-MS/MS.	—

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