Early Phase

With 20 Years of excellence in research, Cliantha offers wide array of early phase services accomplished by our trained professionals. These services can be accessed as part of an integrated program or as a stand-alone service at our clinical or multicentric sites

Experience

India

North America

Various Routes of Administration (dosage forms)

• Injection (IM, IV, Subcutaneous)
• Oral (Tablets: IR,ER,SR,MR,CR,DR,ODT,Chewable)
  • Capsules: ER,MR,DR, Soft Gelatin)
  • Suspension
  • Granules
  • Sublingual
• Rectal (Suppository & Foam)
• Transdermal (Patch, Topical Cream, Topical Gel, Lotion)
• Vaginal (Tablet, Cream, Gel)
• Pulmonary (MDI & Nasal Spray)

BA/BE-Phase 1 Achievements

• Successfully Executed study of Buprenorphine Buccal Film in Phase I setup that involves complex dosing procedure like placing in right/left cheek pouch of each subject’s mouth until dissolution (around 60 minutes) with safety measures like Conmed at specific interval, Continuous Respiratory monitoring in presence of Intensivist.
• 100+ derma/patch BE Studies (Adhesion/PK)
• Successfully conducted the Open First to File study across different Cliantha's geographical locations for Clinic (US), Lab (Canada), PK and Report (India).
• Liposomal Amphotericin B 50 mg injection pivotal study which involves challenges like continuous and precise IV infusion over 2 hours with the help of calibrated infusion pump and possibilities of more adverse events including infusion related reaction which were prevented/well managed with IV ConMed.
• Diclofenac Sodium 37.5 mg/ml injection PK/PD pivotal study which demands very frequent sampling for initial few minutes and PD parameters to be analyzed within 01 to 02 minutes after blood collection.
• Inhalation study on Ipratropium Bromide HFA Inhalation Aerosol 21μg. The study demands extensive training of volunteers with placebo. Specially designed negative pressure rooms were used for dosing to avoid cross contamination
• Irritation and Sensitization (IS) study of Norelgestromin+ Ethinyl Estradiol patch: Two different geographical locations (US & India), all three phases (Induction, Challenge & Re-challenge)” & 310 female subjects.
• 40+ long housing studies (Potassium Chloride/Citrate)
• 88 studies (62 pivotal, 26 pilot) for long washout (Levothyroxine, Enzalutamide, Aripiprazole, Empagliflozin and Linagliptin, Brexpiprazole etc.)
• 154 studies (118 pivotal, 36 pilot) for hormonal preparation(Ethinyl Estradiol+Levonorgestrol, Desogestrel+ Ethinyl Estradiol, Levothyroxine, Methylprednisolone, Prednisolone, Hydrocortisone, Liothyronine, Drospirinone+Ethinyl Estradiol, Norethindrone Acetate +Ethinyl Estradiol etc.)
• 45 studies in elderly population (Brexpiprazole and Aripiprazole)
• Phase I, multiple dose, placebo controlled study to evaluate the safety and tolerability of topical cream having long housing of 15 days
• 06 sublingual tablets studies (Nitroglycerin 0.6 mg) demanding frequent blood sampling
• 12 studies for biosimilars (Darbepoetin, Enoxaparin, Pegfilgrastim, Repoitin, Adalimumab, Trastuzumab etc.)
• Studies with stringent screening criteria, long housing, long washout, high sample size etc (Pegfilgrastim)
• 02 studies (01 pilot, 01 pivotal) for Octreotide depot injection having higher sample size (n=220) and 70 days last ambulatory samples

• 4 clinical units, 771 beds, 22 ICU beds
• 36 bedded Phase I unit
• 100000+ healthy subject database