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IRCT20190706044111N6 IRCT 2019-09-06 Alborzdarou Pharm. Co. 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 2019-11-22 anticipated 24 Complete https://irct.ir/trial/41480 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other. Bioequivalence Neuralgia and neuropathic disorders. Intervention 1: Intervention group: Gabapentin 300mg capsule of Alborzdarou Pharm Co. Intervention 2: Control group: Neurontin 300mg capsule of PFIZER. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Any publication is under permission of Alborzdarou Pharm. Co.
public Ladan Tayebi
1st floor, Saeidi Dd end, Felestin Ave.
Tehran Iran (Islamic Republic of) 1416673971 +98 21 8895 6061 l.tayebi@parsbiopharmacy.com Pars Biopharmacy Research Co. scientific Ladan Tayebi
1st floor, Saeidi Dd end, Felestin Ave.
Tehran Iran (Islamic Republic of) کدپستی: 1416673971 +98 21 8895 6061 l.tayebi@parsbiopharmacy.com Pars Biopharmacy Research Co. Iran (Islamic Republic of) 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 20 years 50 years Both Other Other Intervention group: Gabapentin 300mg capsule of Alborzdarou Pharm Co. Control group: Neurontin 300mg capsule of PFIZER 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. Alborzdarou Pharm. Co. Approved 2019-07-28 Ethics committee of Zahedan University of medical Sciences Dr. Hessabi square Zahedan University of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)