Bio equivalence study of Hydrochlorothiazide 50 mg tablets

Bio equivalence study of Hydrochlorothiazide 50 mg tablets manufactured by Fatak Chemie Pars pharmaceutical company and comparing pharmacokinetics results with Hydrochlorothiazide tablets manufactured by Novartis in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200513047423N4

Enrollment

Registered

2021-11-28

Start date

2021-12-03

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Bioequivalance Hydrochlorothiazide 50 mg.

Interventions

Intervention 1: Intervention group: One Hydrochlorothiazide 50 mg tablet manufactured by Fatak Chime Pars company (Test drug) is administrated to each of 12 healthy volunteers of group 1. Washout peri

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy liver Healthy Kidney Observing BMI Age range between 18 and 50 years Male and female

Exclusion criteria

Exclusion criteria: Smoking Pregnancy

Design outcomes

Primary

Measure	Time frame
Maximum Plasma Concentration (Cmax): after drug administration, gradually the plasma concentrations increase to Cmax. After Cmax, the plasma concentrations decrease regarding to drug elimination phenomena. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography.;Tmax: the time after drug administration take to reach drug plasma concentration to Cmax. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography.;Area under curve (AUC): AUC is obtained by plotting the plasma concentrations against corresponding times. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography.	—

Measure

Time frame

Maximum Plasma Concentration (Cmax): after drug administration, gradually the plasma concentrations increase to Cmax. After Cmax, the plasma concentrations decrease regarding to drug elimination phenomena. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography.;Tmax: the time after drug administration take to reach drug plasma concentration to Cmax. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography.;Area under curve (AUC): AUC is obtained by plotting the plasma concentrations against corresponding times. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir Mehdizadeh

Ofoqh pharmed labratory

farzadkf@yahoo.com+98 21 6673 8727

Outcome results

None listed

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