Subject: Study code PK-19-017, Version-01

I have attended the ethics committee meeting held on 08/05/2020 through zoom meeting and given
the opinion for protocol conditional approval for below mentioned protocol and study code.

Protocol Title:An Open Label, Randomized, 4-Period, 2-Treatment, 2-Sequence, Fully Replicate,
Crossover, Single-Dose Bioequivalence Study of Levodopa/Carbidopa 200 mg/50 mg CR tablet (Test,
Torrent Pharmaceuticals Ltd., India) versus SINEMET® CR Sustained ReleaseTablet containing
Levodopa/Carbidopa 200 mg/50 mg (Reference, MERCK SHARP & DOHME Corporation USA) in
Healthy Human Volunteers under Fasting Condition.

Study Code: PK-19-017, Version-01

With Regards,

Dr. Amar Vyas,

Member Secretary,
Institutional Ethics Committee.