Clinical trial
An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Four Period, Full-replicate, Oral Bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and Valsartan) 97 mg/103 mg Tablets of Novartis Europharm Limited, Irija in Healthy, Adult, Human Subjects Under Fasting Condition.
NCT06922253 is registered in ClinicalTrials.gov with Humanis Saglık Anonim Sirketi as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Four Period, Full-replicate, Oral Bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and Valsartan) 97 mg/103 mg Tablets of Novartis Europharm Limited, Irija in Healthy, Adult, Human Subjects Under Fasting Condition.
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- December 28, 2024
- Completion date
- March 17, 2025
- Enrollment
- 48 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
chronic heart failure