Bioequivalence study of Gabapentin 300mg capsule of Alborzdarou Pharm Co.,

A randomized, open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Gabapentin 300mg capsule of Alborzdarou Pharm Co., IRAN in comparison of Neurontin 300mg capsule of PFIZER in 24 healthy adult subjects under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N6

Enrollment

Registered

2019-09-06

Start date

2019-11-22

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Neuralgia and neuropathic disorders.

Interventions

Intervention 1: Intervention group: Gabapentin 300mg capsule of Alborzdarou Pharm Co. Intervention 2: Control group: Neurontin 300mg capsule of PFIZER.

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Aged between 20 - 50 years Body weight between 50 – 100 kg Having good health on the basis of medical history and physical & clinical examination Understand the procedures and give written informed consent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Plasma concentration of gabapentin. Timepoint: 0 (before dosing), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0 & 24.0 hr. after dosing. Method of measurement: HPLC.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Tayebi

Pars Biopharmacy Research Co.

l.tayebi@parsbiopharmacy.com+98 21 8895 6061

Outcome results

None listed

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