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Effect of Tablet Solifenacin 10mg on transit time from mouth to caecum by Sulfasalazine Method in Healthy Humans.

Effect of Tablet Solifenacin 10mg on Oro-caecal Transit Time by Sulfasalazine Method in Healthy Human Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/018934
Enrollment
12
Registered
2019-05-03
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: Tablet Solifenacin: 10mg singal dose Control Intervention1: Placebo: similar in apperance with intervention tablet. single dose.

Sponsors

Dr Mehdi Ali mirza
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Basal Metabolic Index(BMI) 18.5- 25kg/m2 2.Subjects of normal health as determined by medical history and physical examination. 3.Subjects with screening lab values within normal limits or considered insignificant by physician / investigator. 4.Should comply with all study procedures

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity to any drugs particularly sulfa drugs. 2.History of ingestion of sulfa drugs, prokinetics and loperamide in last 2 weeks. 3.History of ingestion of macrolide antibiotics in last 3 days 4.Regular smoker and has difficulty abstaining from smoking for 48 hours before study 5.Subjects with clinically significant abnormalities / significant disease 6.History of Glaucoma, Urinary or Gastric retention

Design outcomes

Primary

MeasureTime frame
time for apperance of Sulfapyridine will be determined by spectrophotometry of salivary samples.Timepoint: Salivary samples will be collected at 2, 3, 4,5,5.5,6,6.5,7, 7.5,8,8.5, 9,10,11,12, 14, 16, 18, 20, 22, 24 hour post sulphasalzine

Secondary

MeasureTime frame
dryness of mouth by visual analogue scale.Timepoint: 2,4,6,8,10,12,14,16,18,20,22,224 hours post sulfasalzine.

Countries

India

Contacts

Public ContactMehdi Ali Mirza

Nizams Institute of Medical Sciences

adonepudi@yahoo.co.in9160368850

Outcome results

None listed

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