At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
RIN 150 +1 moredrug
Likely dose
RIN 150 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Single Dose, 2-Way Cross-Over Randomized Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 (Contains 150 Mg Rifampicin And 75 Mg Isoniazid Per Tablet) To An Equivalent Dose Of Single Drug Reference Preparations Of Rifampicin And Isoniazid Following Oral Administration In Healthy Adults Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating RIN 150 and reference drugs for Healthy Volunteers. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesSingapore
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
Primary CompletionOct 2012
First PostedDec 2013
TodayJul 2026
First PostedDec 18, 2013
Enrollment StartSep 1, 2012
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.5 years ago
Interventions
RIN 150drug
Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid.
reference drugsdrug
Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.