RANBAXY

INFORMED CONSENT FORM

Title Of Research- A single blind, randomized clinical trial to test

bioequivalence between two formulations of paracetamol/ phenylephrine .

Protocol No.-007

Approved on- 12 July, 2010

Sponsor- RANBAXY

Principal Investigator- Dr. Geet Agarwal

Phone No.- +919015065730

Email- geet@yahoo.com

Co-investigator- Ms.Rachna Bharadwaj

Phone No.- +91901506273

Email- rachna@yahoo.com

Location- Ranbaxy pvt Limited, Guragaon, India

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Purpose of the research- The purpose of the research is to assess

bioequivalence between two paracetamol/phenylephrine combination
products.

Please read this form and ask any questions that you may have about this
research. Your participation is voluntary and you can ask questions at any
time during the research.

Participants in this research should be between18 yrs-50 yrs. Both genders

(Male and Female) are eligible in the research. The total number of
participants is expected to be 40 healthy volunteers.

Condition Intervention Phase

Respiratory Tract Drug: Paracetamol 500mg/phenylephrine 5mg

Infections tablets Phase I

Drug: Paracetamol 1000mg/phenylephrine 10

mg sachet.

Explanation of the procedure-

The duration of the study is 4 months. The study will be a single dose,
randomized, two-way crossover study in 40 healthy subjects, with equal
numbers of males and females. Drop-outs will not be replaced. The two
doses of medication given in the study (a single dose in each of the two
study periods) will be separated by a washout period of at least 7 days. In
each study period, sixteen blood samples for pharmacokinetic analysis will
be taken over 24 hours. Blood samples will be centrifuged and
concentrations of paracetamol and phenylephrine in plasma will be
measured using a validated chromatographic assay. Pharmacokinetic
parameters will be calculated from plasma concentration data. The rate and
extent of absorption of the formulations will be compared.

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ARMS ASSIGNED INTERVENTIONS

Tablet: Experimental Drug: Paracetamol 500mg/phenylephrine 5mg

Paracetamol 500mg/phenylephrine 2 tablets should be administered orally with 240ml of

5mg water with a 24 hour follow-up period

Sachet : Active Comparator Drug: Paracetamol1000mg/phenylephrine 10mg

Paracetamol1000mg/phenylephrine 1 sachet dissolve in 240 ml of water and administered

10mg orally with a 24 hour follow-up period

Voluntary Participation-

Your participation in this research is entirely voluntary. It is your choice

whether to participate or not. Whether you choose to participate or not, all
the services you receive at this clinic will continue and nothing will change.
If you choose not to participate in this research project, you will offered the
treatment that is routinely offered in this clinic/hospital. You may change
your mind later and stop participating even if you agreed earlier.

Risk to be in research-

You may have some side effects from taking these drugs. The side effects
of paracetamol/phenylephrine include diarrhea, nausea, headache and
gas. But they are tolerable. However if you experience emergency physical
or emotional harm as a direct result of your participation in this research,
you will receive free care and treatment from our clinic.

Benefits-

You may not benefit directly from taking part in this research. However, this
study may help us to provide our medicine with significantly same effect
and response in much cheaper price to the needed patients.

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Confidentiality-

The information provided by you will remain confidential. Nobody except

principal investigator will have an access to it. Your name and identity will
also not be disclosed at any time. However the data may be seen by Ethics
review committee and may be published in journal and elsewhere without
giving your name or disclosing your identity.

Payment-

Patient will get Rs.200 to pay for their travel to the clinic/parking and will get
Rs 500 for lost work time. You will not be given any other money or gifts to
take part in this research.

Refusal or withdrawal without penalty-

You do not have to take part in this research if you do not wish to do so.
You may also stop participating in the research at any time you choose. It
is your choice and all of your rights will still be respected.

You may be removed from the study without your consent if the sponsor
ends the study, if the study drug is approved by the FDA, if the study doctor
decides it is not in the best interest of your health, or if you are not following
the study rules.

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Contacts and Questions- The researchers conducting this research are

well qualified. For questions or more information on concerning this
research you may contact them at our helpline no. 1800-2222200.

If you have any questions about your rights as a research participant, the
research itself, or any other research- related injuries, you may contact:

Dr. Arushi Sanghal

Chairman, Ethics Review Committee, Ranbaxy

New Delhi (110021)

Tel: 011-2420000

Email: arushi@gmail.com

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Identification of the investigators-

If you have any questions and concerns about research, please free to
contact

1. Dr. Geet Agarwal

Principal Investigator

Department of Philosophy

Ranbaxy, Guragaon

India

Phone no.: +919015065730

geet@yahoo.com

2. Ms.Rachna Bharadwaj

Co-Investigator

Department of Philosophy

Ranbaxy, Gurgaon

India

Phone no.: +91999917171

rachna@yahoo.com

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STATEMENT OF CONSENT

I have read the foregoing information, or it has been read to me. I have had
the opportunity to ask questions about it and any questions that I have
asked have been answered to my satisfaction. I consent voluntarily to
participate as a participant in this research and understand that I have the
right to withdraw from the research at any time without in any way affecting
my medical care.

Print Name of Participant__________________

Signature of Participant ___________________
Date ___________________________
Day/month/year

If illiterate
A literate witness must sign (if possible, this person should be selected by
the participant and should have no connection to the research team).
I have witnessed the accurate reading of the consent form to the potential
participant, and the individual has had the opportunity to ask questions. I
confirm that the individual has given consent freely.

Print name of witness______________ AND Thumb print of participant

Signature of witness ______________

Date ________________________

I have accurately read or witnessed the accurate reading of the consent

form to the potential participant, and the individual has had the opportunity
to ask questions. I confirm that the individual has given consent freely.

Print Name of Researcher________________________

Signature of Researcher _________________________
Date ___________________________

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