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Ph.D.
(Pharmacy)
SURVEY OF HEALTH ADULT HUMAN PARTICIPANTS OF EARLY
PHASE BIOEQUIVALENCE PHARMACOKINETIC ENDPOINT
STUDY IN GUJARAT STATE OF INDIA
Ph.D. Scholar : Desai Sharad L.
Research Supervisor : Dr. Nilesh J. Patel

Regi. No.: 19276011003
Abstract :
Aim: Study of healthy adult human participants of early phase bioequivalence
pharmacokinetic endpoint study in Gujarat state of India for their demographics,
participation details, awareness level, objectives of participation, factors considered for
participation, overall participation experience, other people’s reasons for not to
participate, reasons to withdraw and not to withdraw the consent even willing to
withdraw.

Method: Newly developed questionnaire was validated by face validity, content validity
and pilot study with 50 participants. After having ethics committee approval, validated
questionnaire was administered in English, Gujarati and Hindi languages in 1250
participants after taking their written consent to participate. Filled questionnaire of 583
(i.e., response rate of 46.64%) participants were considered for statistical analysis after
coding and comparing data by double entry in Microsoft Excel 2013. Statistical analysis
was done with SPSS Version: 25.0 and SAS Version: 9.4 for windows for descriptive and
inferential statistics.

Results: Developed questionnaire passed validity tests. Out of 583 Indian participants,
81.8% participants were from age range of 26 to 41 years. All participants had income up
to Rupees 4,50,000. Only 14.2% participants had education of graduation and post-
graduation. 69.6% participants were holding private job or wage-earner. Around 75%
participants were married and staying in chawl or cottage. 45.5% of participants had
started participation at ages like 20 years, 26 years and 30 years. 82.2% of participants
had participated more than once and 95.2% participants were agreeing that Government
of India should allow to conduct such studies. Awareness level of participants was not
high or low but was average. Top rated objective for participation was ‘to get money’ and
factor considered for participation was ‘relation with screening team of CRO’. ‘Overall
experience is good’ was rated top among other experience for overall participation
experience. ‘Their family restriction’ and ‘past participation experience’ were ranked at top
among nine reasons, due to that other people are not participating. Highest ranked
reason to withdraw consent was ‘Less compensation, realized later’ while, ‘Losing proper
future medical care, if required’ was for not to withdraw the consent even participant

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