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Pilot study to test and validate the applicability of a bioanalytical assay for betahistine in plasma after administration of a single dose betahistine 24 mg IR tablet

A pilot study to test and validate the applicability of a bio-analytical assay for betahistine in plasma obtained from healthy male subjects after administration of a single dose of the marketed betahistine 24 mg IR tablet - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/08/001934
Enrollment
8
Registered
2011-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Vertin IR 24 mg: Each tablet contains Betahistine 24 mg Control Intervention1: not applicable: it is single arm study

Sponsors

Abbott Healthcare Products BV
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: � BMI 18 - 28 kg/m2

Exclusion criteria

Exclusion criteria: ? Subjects who participated in a previous betahistine trial ? Subjects who can not communicate reliable with the investigator ? Subjects who are unlikely to co-operate with the requirements of the study

Design outcomes

Primary

MeasureTime frame
Cmax, tmax, λz, t1/2, AUC0-t and AUC for both betahistine and metabolite 2-Pyridyl Acetic Acid ; CL/F and Vz/F for betahistine only Timepoint: Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose).—

Secondary

MeasureTime frame
adverse event and concomitant medication recording.Timepoint: Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose).;Safety assessments including medical and drug history, physical examination, vital signs, 12-lead ECG, safety laboratory tests, viral serology, urine drug screen / alcohol breath testTimepoint: Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose).—

Countries

India

Contacts

Public ContactDr Sakharam Garale

Lambda Therapeutic Research Ltd

alpeshpatel@lambda-cro.com07940202282

Outcome results

None listed

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