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topic_facet:"Phase: Phase 1"
topic_facet:"Study Type: BA/BE"
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PubPharm (180)
1
Bio-equivalence study of Biphasic Insulin Aspart Injection (30/70) : A Randomized, Single Center, Double Blind, Two-Period,Crossover Glucose Clamp Study to Test for Bioequivalencebetween Two Recombinant Human Insulin Analogues -Wockhardtâ??s Biphasic Insulin Aspart Injection (30/70) andNovomix® 30, in Healthy Subjects - W-ASP (B)-103
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| 2023
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2
Bio-equivalence study of Biphasic Insulin Aspart Injection (30/70) : A Randomized, Single Center, Double Blind, Two-Period,Crossover Glucose Clamp Study to Test for Bioequivalencebetween Two Recombinant Human Insulin Analogues -Wockhardtâ??s Biphasic Insulin Aspart Injection (30/70) andNovomix® 30, in Healthy Subjects - W-ASP (B)-103
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| 2023
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3
Open-label single-dose dose escalation fasting food effect and multiple dose fasting study. : Open-label, single-dose, six-treatment, *eight-cohort, oral bioavailability, dose escalation fasting, food effect and multiple dose fasting study of (+)-α-DHTBZ 5 mg, 7.5 mg, 10 mg, 15 mg and 22.5 mg powder in healthy, adult, human subjects.*New Cohort i.e. cohort 08 will be conducted using fresh 06 subjects only if Dose Limiting Toxicities (DLTâ??s) observed in highest dose is less than or equal to 33%. If DLTâ??s observed are above 33% then no new cohort will be enrolled, and previous dose will be considered as Maximum Tolerable Dose (MTD).
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| 2023
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4
Open-label single-dose dose escalation fasting food effect and multiple dose fasting study. : Open-label, single-dose, six-treatment, *eight-cohort, oral bioavailability, dose escalation fasting, food effect and multiple dose fasting study of (+)-α-DHTBZ 5 mg, 7.5 mg, 10 mg, 15 mg and 22.5 mg powder in healthy, adult, human subjects.*New Cohort i.e. cohort 08 will be conducted using fresh 06 subjects only if Dose Limiting Toxicities (DLTâ??s) observed in highest dose is less than or equal to 33%. If DLTâ??s observed are above 33% then no new cohort will be enrolled, and previous dose will be considered as Maximum Tolerable Dose (MTD).
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| 2023
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5
Randomized, Crossover Trial : An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period,Crossover Oral Bioequivalence Study Comparing Gliclazide and Metformin Extended ReleaseTablets 60 mg / 500 mg manufactured by Servier India Private Limited with Glycinorm M OD(Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500 mg) Tablets(Indian innovator) Manufactured by IPCA Laboratories, India in Healthy, Adult, Human MaleSubjects Under Fasting Conditions. - BA/BE Study
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| 2023
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6
Randomized, Crossover Trial : An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period,Crossover Oral Bioequivalence Study Comparing Gliclazide and Metformin Extended ReleaseTablets 60 mg / 500 mg manufactured by Servier India Private Limited with Glycinorm M OD(Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500 mg) Tablets(Indian innovator) Manufactured by IPCA Laboratories, India in Healthy, Adult, Human MaleSubjects Under Fasting Conditions. - BA/BE Study
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| 2023
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7
A clinical trial study to determine the bioavailability of different formulations of curcumin tablets. : An open-label, balanced, randomized, single-dose, two-treatment, two-period, two-way crossover, relative bioavailability study of two different formulations of Curcumin 10 mg orally soluble tablet manufactured by KMS Health Center Pvt. Ltd., East Tambaram, Selaiyur, Chennai and Curcunex G 5 mg manufactured by Stabicon Life Science Pvt. Ltd., Plot No 28, Bommasandra industrial area (Sub layout), 4th Phase, Jigani Hobli, Anekal Taluk, Bangalore, Karnataka- 560100. Marketed by Yeus Life science Pvt Ltd, A-IO, Art gold house, Lbs Marg, Mumbai 400070 in healthy, adult, human, male subjects under fasting conditions.
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| 2022
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8
A clinical trial study to determine the bioavailability of different formulations of curcumin tablets. : An open-label, balanced, randomized, single-dose, two-treatment, two-period, two-way crossover, relative bioavailability study of two different formulations of Curcumin 10 mg orally soluble tablet manufactured by KMS Health Center Pvt. Ltd., East Tambaram, Selaiyur, Chennai and Curcunex G 5 mg manufactured by Stabicon Life Science Pvt. Ltd., Plot No 28, Bommasandra industrial area (Sub layout), 4th Phase, Jigani Hobli, Anekal Taluk, Bangalore, Karnataka- 560100. Marketed by Yeus Life science Pvt Ltd, A-IO, Art gold house, Lbs Marg, Mumbai 400070 in healthy, adult, human, male subjects under fasting conditions.
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| 2022
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9
Study of Sunitinib malate Capsules 50mg among cancer patients under treatment with stable dose of Sunitinib malate capsules conducted at multiple centers in India where patients will be treated with Sutent 50mg (as Reference) and Sunitinib 50mg by Reliance LIfe Sciences Pvt Ltd : A randomized, multi-center, open-label, two-treatment, two-sequence, two-period, crossover, steady state bioequivalence study of Sunitinib Malate 50 mg hard capsules manufactured byReliance Life Sciences Pvt. Ltd., India with reference SUTENT�® (Sunitinib Malate 50 mg hard(capsules) distributed by Pfizer Labs, Division of Pfizer Inc., NY in adult cancer patients under treatment with stable dose of Sunitinib malate capsules under non-fasting (fed) condition
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| 2022
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10
A clinical trial in Steady state Bioequivalence Study of Sunitinib Malate Capsules 50 mg with Sutent capsules 50 mg in adult patients with advanced renal cell carcinoma already receiving stable dose of Sunitinib Malate Capsules 50 mg under fasting conditions : A Multicentric Open label Randomized Two Period Two Treatment Two Sequence Crossover Multiple Dose Steady state Bioequivalence Study of Sunitinib Malate Capsules 50 mg of Eugia Pharma Specialities Limited India with Sutent capsules 50 mg of Pfizer Labs USA in adult patients with advanced renal cell carcinoma already receiving stable dose of Sunitinib Malate Capsules 50 mg under fasting conditions
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| 2022
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Phase: Phase 1
Study Type: BA/BE
98
Recruitment Status: Completed
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10
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Medical Condition: Health Condition 1: C509- Ma...
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Erscheinungszeitraum
6
2023
16
2022
158
2021
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