bioequivalence study of Baclofen 25mg tablet of Amin Pharm Co., IRAN in comparison of Lioresal 25mg tablet of Novartis

A randomized, open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Baclofen 25mg tablet of Amin Pharm Co., IRAN in comparison of Lioresal 25mg tablet of Novartis in 24 healthy man adult subjects under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N2

Enrollment

Registered

2019-08-14

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

Muscle spastic.

Interventions

Intervention 1: Intervention group: Baclofen 2* 25mg tablet of Amin Pharm Co.,. Intervention 2: Control group: Lioresal 25mg tablet of Novartis.

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: Subject showed clinically relevant deviations from normal in physical examination. Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment. Subject had a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment. Subject had a history of allergic to

Design outcomes

Primary

Measure	Time frame
Plasma concentration of baclofen. Timepoint: 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 & 12.0 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