Phenytoin capsules bioequivalence

Bioequivalence study of the Phenytoin 100 mg Capsules manufactured by Vana Darou Gostar Pharmaceutical Company vs. Dilantin® Capsules manufactured by Pfizer Pharmaceutical Company in healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130313012810N56

Enrollment

Registered

2025-05-06

Start date

2025-05-15

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

Bioequivalence study in healthy volunteers.

Interventions

Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of Phenytoin 100-mg capsules manufactured by Vana Darou Gostar Pharmaceutical Company. In each period, 12 o

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: The weight range of participating candidates should be between 60-100 kg Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose. Volunteers who have agreed to an informed consent form. All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw All candidates must be non-smokers

Exclusion criteria

Exclusion criteria: History of allergic or adverse reaction to Phenytoin or any similar product Volunteers with blood pressure less than 90/60mm Hg or higher than 140/90mm Hg. Individuals who have donated whole blood during the last 2 months Individuals who have donated blood components, such as platelets, within the past 2 weeks

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: 16 sampling time included pre-dose (time 0) and at the following hours post-dose: 1? 2? 2.5? 3? 3.5? 4? 5? 6? 7? 8? 10? 12? 24? 48 and 72 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Hamishehkar

Tabriz University of Medical Sciences

hamishehkar.hamed@gmail.com+98 41 3336 3181

Outcome results

None listed

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