A bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting condition

A cross over bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

IRCT

Registry ID

IRCT20220209053979N2

Enrollment

Registered

2022-07-07

Start date

2022-06-30

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Blood concentration of test and reference drug is compared.

Interventions

Intervention 1: Intervention group: Oral administration of a single dose of 1 tablet of losartan H 50/12.5 mg of Alborz Darou to 12 healthy volunteers under fasting condition with 240 ml water, then

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Sex: male.Age: 18 - 55 years. . BMI of 18-27 kg/m2 with minimum of 50 kg weight. Volunteer willing to adhere to the protocol requirements and to provide written informed consent Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion criteria

Exclusion criteria: Clinically relevant abnormalities in the results of the laboratory screening evaluation. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. Pulse rate less than 50/minute or more than 100/minute. History of allergy to the test drug or any drug chemically similar to the drug under investigation. History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study

Design outcomes

Primary

Measure	Time frame
The plasma concentrations of the test and reference drugs is compared. A total of 16 blood samples are taken from each volunteer at different times. Timepoint: , 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 , 24 , 36 hours after drug administration. Method of measurement: liquid chromatography mass spectrometry (LCMSMS).	—

Secondary

Measure	Time frame
Plasma concentration of the drug and consequently y pharmacokinetic parameters such as maximum plasma concentration and area under curve of the concentration-time profile of test and reference drug. Timepoint: , 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 , 24 , 36 hours after drug administration. Method of measurement: Plasma concentration of the drug is analyzed by liquid chromatography with mass detector.	—

Measure

Time frame

Plasma concentration of the drug and consequently y pharmacokinetic parameters such as maximum plasma concentration and area under curve of the concentration-time profile of test and reference drug. Timepoint: , 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 , 24 , 36 hours after drug administration. Method of measurement: Plasma concentration of the drug is analyzed by liquid chromatography with mass detector.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Talari

Kharazmi Plasma Center

talari_r@yahoo.com+98 21 5669 4726

Outcome results

None listed

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