Bioequivalence of sustained release memeantin 21 mg capsule manufactured by Tasinm Pharmaceutical and namenda manufactured by Forest Laboratory

Bioequivalence Study of sustained release memeantin 21 mg capsule manufactured by Tasinm Pharmaceutical and Namenda 21 capsule manufactured by Forest Laboratory in 24 Healthy Volunteers under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220209053979N13

Enrollment

Registered

2023-12-09

Start date

2023-12-14

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

A crossover bioequivalence study in 24 healthy volunteers.

Interventions

Intervention 1: Intervention group: Oral administration of one memantin 21 mg capsule manufactured by Tasnim Pharmaceutical to 12 healthy volunteers under fasting condition with 240 ml of water. Then

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy male or female volunteers Body mass index (BMI) between 18 - 30 Volunteers who are willing to sign an informed consent form

Exclusion criteria

Exclusion criteria: History of allergic reaction to memantin or formulation components Taking any type of medicine in the 14 days before the start of the study Participation in any type of clinical study in the last month History of arrhythmia

Design outcomes

Primary

Measure	Time frame
Plasma concentration time profile, maximum plasma concentration, AUC. Timepoint: 0, 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 48, 72 h. Method of measurement: Liquid chromatography with mass spectrophotometry.	—

Secondary

Measure	Time frame
Calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: Same as primary outcome. Method of measurement: Pharmacokientic parameters are calculated by excel.	—

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